Company ยท US
Medtronic Neurosurgery
FDA 510(k) clearances and medical device recalls filed under this name, 2001 to 2025. Name variants (Inc, Corp, punctuation) are merged.
28510(k) clearances (0 in 12 months)
68recalls (1 in 12 months)
61recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JXG | Shunt, Central Nervous System And Components | 67 |
| PCB | External Cerebrospinal Fluid (Csf) Diversion | 7 |
| GWG | Endoscope, Neurological | 6 |
| GXQ | Dura Substitute | 5 |
| HBO | Clip, Scalp | 3 |
| GWM | Device, Monitoring, Intracranial Pressure | 2 |
| FZP | Clip, Implantable | 1 |
| GXL | Screwdriver, Skullplate | 1 |
| GXN | Plate, Cranioplasty, Preformed, Non-Alterable | 1 |
| HBG | Drills, Burrs, Trephines & Accessories (Manual) | 1 |
| HWC | Screw, Fixation, Bone | 1 |
| KYZ | Syringe, Irrigating (Non Dental) | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 10, 2025 | K243676 | Duet External Drainage and Monitoring System (EDMS) Medtronic Neurosurgery | JXG |
| Oct 24, 2024 | K242034 | Duet External Drainage and Monitoring System (EDMS) Medtronic Neurosurgery | PCB |
| Sep 16, 2021 | K212641 | StrataMR II Valves and Shunts Medtronic Neurosurgery | JXG |
| Oct 1, 2018 | K181622 | StrataMR guider tool Medtronic Neurosurgery | JXG |
| Nov 2, 2016 | K161370 | Durepair Dura Regeneration Matrix Medtronic Neurosurgery | GXQ |
| Apr 7, 2016 | K152700 | StrataMR Valves and Shunts Medtronic Neurosurgery | JXG |
| Aug 22, 2014 | DEN120017 | Medtronic DUET External Drainage and Monitoring System Medtronic Neurosurgery | PCB |
| Feb 13, 2013 | K123524 | MEDTRONIC STRATA NSC LUMBOPERITONEAL VALVE AND SHUNT SYSTEM Medtronic Neurosurgery | JXG |
| Nov 18, 2011 | K110560 | MEDTRONIC ARES ANTIBIOTIC-IMPREGNATED CATHETER Medtronic Neurosurgery | JXG |
| Sep 2, 2009 | K091312 | PS MEDICAL STRATA NSC LUMBOPERITONEAL VALVE AND SHUNT SYSTEM Medtronic Neurosurgery | JXG |
| Nov 20, 2008 | K083076 | STRATA BURR HOLE VALVE, MODEL 42836 AND STRATA BURR HOLE SHUNT ASSEMBLY, MODEL 46836 Medtronic Neurosurgery | JXG |
| Aug 27, 2008 | K082127 | STRATA NSC BURR HOLE VALVE, MODEL 42335; SHUNT ASSEMBLY, MODEL 46635 Medtronic Neurosurgery | JXG |
| Jan 30, 2008 | K073139 | SMALL LUMEN PERITONEAL CATHETER Medtronic Neurosurgery | JXG |
| Aug 16, 2007 | K063836 | RIVULET VENTRICULAR AND SNAP SHUNT AND CONVERTIBLE VENTRICULAR CATHETERS, MODELS 41701 AND 41704-41715 Medtronic Neurosurgery | JXG |
| Dec 19, 2006 | K062821 | U-CLIP DEVICE Medtronic Neurosurgery | FZP |
| Nov 3, 2006 | K063117 | MODIFICATION TO DUREPAIR DURA REGENERATION MATRIX Medtronic Neurosurgery | GXQ |
| Sep 15, 2006 | K060681 | MEDTRONIC PS MEDICAL STRATA TYPE VALUE Medtronic Neurosurgery | JXG |
| Sep 8, 2006 | K062348 | TIMESH SELF DRILLING SCREW Medtronic Neurosurgery | HWC |
| Dec 16, 2005 | K052386 | MEDTRONIC M2 MAGNET ADJUSTMENT TOOL Medtronic Neurosurgery | JXG |
| Sep 14, 2005 | K052211 | DUREPAIR DURA REGENERATION MATRIX Medtronic Neurosurgery | GXQ |
| Feb 7, 2005 | K050044 | MEDTRONIC CLIP GUN KIT Medtronic Neurosurgery | HBO |
| Jan 28, 2005 | K041992 | MEDTRONIC STRATAVARIUS Medtronic Neurosurgery | JXG |
| Oct 19, 2004 | K042465 | PS MEDICAL STRATA II VALVE Medtronic Neurosurgery | JXG |
| Sep 24, 2004 | K042198 | PS MEDICAL NEUROSURGICAL IMPLANTS Medtronic Neurosurgery | JXG |
| Jul 27, 2004 | K041000 | DUREPAIR DURA REGENERATION MATRIX Medtronic Neurosurgery | GXQ |
| Jun 15, 2004 | K040943 | MEDTRONIC PS MEDICAL STRATA VALVE Medtronic Neurosurgery | JXG |
| Jan 13, 2004 | K033850 | MEDTRONIC PS MEDICAL STRATA NSC VALVE AND SHUNT ASSEMBLIES WITH AND WITHOUT BIOGLIDE Medtronic Neurosurgery | JXG |
| Dec 5, 2001 | K013000 | MEDTRONIC INVISX BURR HOLE LOCK, MODEL 60520 Medtronic Neurosurgery | GXN |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 21, 2026 | Medtronic Neurosurgery Ventriculostomy Kit, REF: 46154 Open, Classified |
HBG | K915546 |
| Dec 19, 2024 | Medtronic Neurosurgery Exacta External Drainage and Monitoring System:
27581 KIT 27581 EXACTA W/EDM VCATH 35CM
27636 EDM 27636 EXACTA W/BRAIDED CORD LOCK
27666 EDM 27666 EXCTA W GLUE STPCK GR PT LN
27732 EDM 27732 EXACTA W/ Open, Classified |
GWM | K200456 |
| Dec 19, 2024 | Medtronic Neurosurgery Becker External Drainage and Monitoring System:
24146 EDMS 24146 BECKER NO Y-SITE
25120 EDMS II 25120 BECKER W/1-WAY VALVE
26040 KIT 26040 BECKER EDMS II
27609 BECKER 27609 W/NEEDLESLESS INJ. SITE
276 Open, Classified |
GWM | K200456 |
| Feb 27, 2024 | Medtronic Neurosurgery Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Lumbar Catheter, REF 46917, Sterile EO, Rx Only. Used to drain cerebrospinal fluid (CSF) as a means to reduce intracr Open, Classified |
PCB | None listed |
| Feb 27, 2024 | Medtronic Neurosurgery Medtronic Duet External Drainage and Monitoring System, SmartSite Injection Sites, Ventricular Catheter, REF 46916, Sterile EO, Rx Only. Used to drain cerebrospinal fluid (CSF) as a means to reduce in Open, Classified |
PCB | None listed |
| Feb 27, 2024 | Medtronic Neurosurgery Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Ventricular Catheter, REF 46915, Sterile EO, Rx Only. Used to drain cerebrospinal fluid (CSF) as a means to reduce in Open, Classified |
PCB | None listed |
| Feb 27, 2024 | Medtronic Neurosurgery Medtronic Duet External Drainage and Monitoring System, SmartSite, Injection Sites, REF 46914, Sterile EO, Rx Only. Used to drain cerebrospinal fluid (CSF) as a
means to reduce intracranial pressure a Open, Classified |
PCB | None listed |
| Feb 27, 2024 | Medtronic Neurosurgery Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, REF 46913, Sterile EO, Rx Only. Used to drain cerebrospinal fluid (CSF) as a
means to reduce intracranial pressure an Open, Classified |
PCB | None listed |
| Aug 17, 2023 | Medtronic Neurosurgery Medtronic REF 46915 Duet External Drainage and Monitoring system, Interlink Injection sites, Ventricular Catheter, STERILE EO, Rx Only Open, Classified |
JXG | K984053 |
| Jul 20, 2023 | Medtronic Neurosurgery Durepair Dura Regeneration Matrix:
DUREPAIR DURA SUBSTITUTE 2 X 2, 61100;
DUREPAIR DURA SUBSTITUTE 3 X 3, 61105;
DUREPAIR DURA SUBSTITUTE 1 X 3, 61106;
DUREPAIR DURA SUBSTITUTE 4 X 5, 61110;
DUREPAIR Open, Classified |
GXQ | K161370 |
| Jan 11, 2021 | Medtronic Neurosurgery Medtronic PS Medical Cerebro Spinal Fluid (CSF)-Flow Control Valves for the following CFNs:
22011 L- SHUNT 22011 L INTL ONLY ULTRA SM LOW
22011 LL - SHUNT 22011 LL INTL ONLY ULTRA SM L-L
22011 M - Open, Classified |
JXG | K792007 K831678 +3 |
| Jan 11, 2021 | Medtronic Neurosurgery Medtronic Cerebro Spinal Fluid Flow Control Valves and Shunts. STRATA II Valves and Shunts for the following CFNs:
27739 - SHUNT 27739 STRATA NSC SNAP SML 120CM,
27740 - SHUNT 27740 STRATA NSC SNA Open, Classified |
JXG | K033850 K042465 +3 |
| Jan 11, 2021 | Medtronic Neurosurgery Medtronic Delta CSF (Cerebro Spinal Fluid) -Flow Control Valves for the following CFNs/REF numbers:
24048 - VALVE 24048 DELTA RGL PL 0.5,
24053 - CHAMBER 24053 DELTA,
24147 - VALVE 24147 DELTA SML P Open, Classified |
JXG | K042465 K862907 +2 |
| Dec 16, 2020 | Medtronic Neurosurgery REF 27219-5 X1, Medtronic, Delta Valve, Neonatal, Performance Level 1.5, CE 0344, Sterile EO - Product Usage: Neonatal Delta Snap Shunt Assemblies are components of CSF-Flow Control Shunt Systems des Open, Classified |
JXG | K902783 |
| Dec 16, 2020 | Medtronic Neurosurgery REF 27219-2 X1, Medtronic, Delta Valve, Neonatal, Performance Level 2.0, CE 0344, Sterile EO - Product Usage: Neonatal Delta Snap Shunt Assemblies are components of CSF-Flow Control Shunt Systems des Open, Classified |
JXG | K902783 |
| Dec 16, 2020 | Medtronic Neurosurgery REF 27219-1 X1, Medtronic, Delta Valve, Neonatal, Performance Level 1.0, CE 0344, Sterile EO - Product Usage: Neonatal Delta Snap Shunt Assemblies are components of CSF-Flow Control Shunt Systems des Open, Classified |
JXG | K902783 |
| Dec 8, 2020 | Medtronic Neurosurgery Medtronic Ares Antibiotic-Impregnated Catheter, REF: 95001, Sterile, Rx Only. Used in the treatment of hydrocephalus as a component of a shunt system when draining or shunting of cerebrospinal fluid Open, Classified |
JXG | K110560 |
| Dec 8, 2020 | Medtronic Neurosurgery Medtronic Ares Antibiotic-Impregnated Catheter, REF: 93092, Sterile, Rx Only.
Used in the treatment of hydrocephalus as a component of a shunt system when draining or shunting of cerebrospinal fluid Open, Classified |
JXG | K110560 |
| Dec 8, 2020 | Medtronic Neurosurgery Medtronic Ares Antibiotic-Impregnated Catheter, REF: 91101, Sterile, Rx Only.
Used in the treatment of hydrocephalus as a component of a shunt system when draining or shunting of cerebrospinal fluid Open, Classified |
JXG | K110560 |
| May 3, 2018 | Medtronic Neurosurgery Medtronic Clip Gun Magazines are packaged in individually sealed pouches and distributed in boxes containing 5 individually pouched Clip Gun Magazine.
REF CM8902, Medtronic Clip Gun Magazine, Rx only Terminated |
HBO | K050044 |
| Dec 20, 2017 | Medtronic Neurosurgery Model #: CG8900, Medtronic Clip Gun Scalp Clip Kit (Qty 1); Model #: CG8901, Medtronic Clip Gun Scalp Clip Kit (Qty 10); Model #: CG8901A, Medtronic Clip Gun Applicator (Qty 10) Terminated |
HBO | K050044 |
| Apr 7, 2017 | Medtronic Neurosurgery The Medtronic StrataMR adjustable valves and shunts are designed to provide continuous cerebrospinal fluid (CSF) flow from the ventricles of the brain into the right atrium of the heart or the periton Terminated |
JXG | K152700 |
| Feb 2, 2017 | Medtronic Neurosurgery Medtronic Strata II / Strata NSC Valves (includes Burr Hole and Lumbar Peritoneal. All Catalog Numbers.
Strata-type valves are used in the management of hydrocephalus. The Strata II/Strata NSC valve Terminated |
JXG | K033850 K042465 +2 |
| Jun 27, 2014 | Medtronic Neurosurgery Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Lumbar Catheter, Catalog No. 46917.
Intended to allow drainage and measurement of cerebrospinal fluid (CSF) and othe Terminated |
JXG | K984053 |
| Jun 27, 2014 | Medtronic Neurosurgery Medtronic Duet External Drainage and Monitoring System, SmartSite Injection Sites, Ventricular Catheter, Catalog No. 46916.
Intended to allow drainage and measurement of cerebrospinal fluid (CSF) and Terminated |
JXG | K984053 |
| Jun 27, 2014 | Medtronic Neurosurgery Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Ventricular Catheter, Catalog No. 46915.
Intended to allow drainage and measurement of cerebrospinal fluid (CSF) and Terminated |
JXG | K984053 |
| Jun 27, 2014 | Medtronic Neurosurgery Medtronic Duet External Drainage and Monitoring System, SmartSite Injection Sites, Catalog No. 46914.
Intended to allow drainage and measurement of cerebrospinal fluid (CSF) and other fluids of simil Terminated |
JXG | K984053 |
| Jun 27, 2014 | Medtronic Neurosurgery Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Catalog No. 46913.
Intended to allow drainage and measurement of cerebrospinal fluid (CSF) and other fluids of simil Terminated |
JXG | K984053 |
| Nov 26, 2013 | Medtronic Neurosurgery Medtronic Strata II Shunt Assembly Kit, Small, Catalog No. 27848.
Strata II Shunt Assemblies are designed to provide continued cerebrospinal fluid (CSF) flow from the ventricles of the brain into th Terminated |
JXG | K042465 |
| Nov 26, 2013 | Medtronic Neurosurgery Medtronic Delta Shunt Assembly Kit with Bioglide Small, Performance Level 1.0, Catalog No. 276201.
Delta Shunt Assemblies are designed for use in shunting CSF from the lateral ventricle of the brain Terminated |
JXG | K902783 |
| Nov 26, 2013 | Medtronic Neurosurgery CSF-Unitized Shunt, Contoured Regular, Low Pressure, Catalog No. 46022;
CSF-Unitized Shunt, Contoured Regular, Medium Pressure, Catalog No. 46024; CSF-Unitized Shunt, Contoured Regular, High Pressure, Terminated |
JXG | K792005 K792007 +1 |
| Jul 25, 2013 | Medtronic Neurosurgery Medtronic Preimplantation Test Kit, Catalog No. 21047. The kit is indicated for use with Medtronic CSF-Flow Control Valves and Delta Valves, when a simple preimplantation test is desired to verify tha Terminated |
KYZ | None listed |
| Mar 27, 2009 | Medtronic Neurosurgery Medtronic Snap Shunt Ventricular Catheter, Standard, with BioGlide, 11 CM, Ref 27802J. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed po Terminated |
JXG | K792007 K874498 +2 |
| Mar 27, 2009 | Medtronic Neurosurgery Medtronic Snap Shunt Ventricular Catheter, Standard, with BioGlide, 10 CM, Ref 27802H. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed po Terminated |
JXG | K792007 K874498 +2 |
| Mar 27, 2009 | Medtronic Neurosurgery Medtronic Snap Shunt Ventricular Catheter, Standard, with BioGlide, 9 CM, Ref 27802G. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed pou Terminated |
JXG | K792007 K874498 +2 |
| Mar 27, 2009 | Medtronic Neurosurgery Medtronic Snap Shunt Ventricular Catheter, Standard, with BioGlide, 8 CM, Ref 27802F. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed pou Terminated |
JXG | K792007 K874498 +2 |
| Mar 27, 2009 | Medtronic Neurosurgery Medtronic Snap Shunt Ventricular Catheter, Standard, with BioGlide, 7 CM, Ref 27802E. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed pou Terminated |
JXG | K792007 K874498 +2 |
| Mar 27, 2009 | Medtronic Neurosurgery Medtronic Snap Shunt Ventricular Catheter, Standard, with BioGlide, 6 CM, Ref 27802D. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed pou Terminated |
JXG | K792007 K874498 +2 |
| Mar 27, 2009 | Medtronic Neurosurgery Medtronic Snap Shunt Ventricular Catheter, Standard, with BioGlide, 5 CM, Ref 27802C. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed pou Terminated |
JXG | K792007 K874498 +2 |
| Mar 27, 2009 | Medtronic Neurosurgery Medtronic Snap Shunt Ventricular Catheter, Standard, with BioGlide, 4 CM, Ref 27802B. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed pou Terminated |
JXG | K792007 K874498 +2 |
| Mar 27, 2009 | Medtronic Neurosurgery Medtronic Snap Shunt Ventricular Catheter, Standard, with BioGlide, 3 CM, Ref 27802A. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed pou Terminated |
JXG | K792007 K874498 +2 |
| Mar 27, 2009 | Medtronic Neurosurgery Snap Shunt Ventricular Catheter, Standard, with BioGlide, 11 CM, Ref 27708J Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed pouch is then Terminated |
JXG | K792007 K874498 +2 |
| Mar 27, 2009 | Medtronic Neurosurgery Snap Shunt Ventricular Catheter, Standard, with BioGlide, 10 CM, Ref 27708H. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed pouch is the Terminated |
JXG | K792007 K874498 +2 |
| Mar 27, 2009 | Medtronic Neurosurgery Snap Shunt Ventricular Catheter, Standard, with BioGlide, 9CM, Ref 27708G. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed pouch is then Terminated |
JXG | K792007 K874498 +2 |
| Mar 27, 2009 | Medtronic Neurosurgery Snap Shunt Ventricular Catheter, Standard, with BioGlide, 3 CM, Ref 27708F. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed pouch is then Terminated |
JXG | K792007 K874498 +2 |
| Mar 27, 2009 | Medtronic Neurosurgery Snap Shunt Ventricular Catheter, Standard, with BioGlide, 8 CM, Ref 27708E. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed pouch is then Terminated |
JXG | K792007 K874498 +2 |
| Mar 27, 2009 | Medtronic Neurosurgery Snap Shunt Ventricular Catheter, Standard, with BioGlide, 7 CM, Ref 27708D. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed pouch is then Terminated |
JXG | K792007 K874498 +2 |
| Mar 27, 2009 | Medtronic Neurosurgery Snap Shunt Ventricular Catheter, Standard, with BioGlide, 6 CM, Ref 27708C. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed pouch is then Terminated |
JXG | K792007 K874498 +2 |
| Mar 27, 2009 | Medtronic Neurosurgery Snap Shunt Ventricular Catheter, Standard, with BioGlide, 5 CM, Ref 27708B. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed pouch is then Terminated |
JXG | K792007 K874498 +2 |
| Mar 27, 2009 | Medtronic Neurosurgery Snap Shunt Ventricular Catheter, Standard, with BioGlide, 4 CM, Ref 27708A. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed pouch is then Terminated |
JXG | K792007 K874498 +2 |
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