ClearanceBrief
Panels › Neurology › Product code JXG · Class 2

Shunt, Central Nervous System And Components

Regulation 882.5550

5510(k)s in 12 months (260 all time)
1recalls in 12 months (108 all time)
103recalls that name a 510(k)
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Top companies in JXG

Company510(k)sRecalls
Medtronic Neurosurgery1849
Codman & Shurtleff, Inc.2319
Integra LifeSciences Corporation1421
Holter-Hausner Intl.210
Aesculap, Inc.146
Cordis Corp.180
Pudenz-Schulte Medical Research Corp.180
Phoenix Biomedical111
Radionics, Inc.100
Sophysa100
Decided510(k)Device and applicantCode
Oct 2, 2026K260044Ventricular Catheters, Thomale Catheter
Aesculap, Inc.
JXG
Jun 23, 2026K261004Codman® Distal Peritoneal Catheter, Barium Open End (82-1682); Codman® HOLTER® Peritoneal Catheter (SALMON Design) (82-1
Integra Lifesciences Production Corporation
JXG
Dec 10, 2025K251598Intellidrop
Brainspace, Inc.
JXG
Nov 28, 2025K250636Sophy Mini Monopressure Valve (SM1)
Sophysa, FR
JXG
Nov 5, 2025K252514EVAC-MRI
Phasor Health, LLC
JXG
Aug 8, 2025K243531Codman Libertís Shunt Catheter with Bactiseal and Endexo Technology
Integra Lifesciences Production Corporation
JXG
Aug 6, 2025K243552Codman Libertís™ 1.5 mm EVD Catheter with Bactiseal® and Endexo® Technology with Luer Connection (821761); Codman Libert
Integra Lifesciences Production Corporation
JXG
Jun 20, 2025K242974External CSF Drainage Ventricular Catheters, External CSF Drainage Lumbar Catheters
Sophysa, FR
JXG
Jun 3, 2025K243205EVAC
Phasor Health, LLC
JXG
Mar 10, 2025K243676Duet External Drainage and Monitoring System (EDMS)
Medtronic Neurosurgery
JXG
Dec 16, 2024K242003XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter Set
Aesculap, Inc.
JXG
Aug 20, 2024K241458Borvo EVAC System (Ergo); Borvo EVAC System (Classic)
Borvo Medical, Inc.
JXG
Jan 17, 2024K233445Bactiseal Catheters; Bactiseal Barium Striped Catheters; Bactiseal Endoscopic Ventricular Catheter
Integra Lifesciences Production Corporation
JXG
Dec 19, 2023K233448Bactiseal EVD Catheter Sets; Bactiseal Clear EVD Catheter Set
Integra Lifesciences Production Corporation
JXG
Oct 19, 2023K231664IRRAflow Active Fluid Exchange System (AFES)
Irras USA, Inc.
JXG
Feb 9, 2023K221694External Drainage System
Jmed(Shenzhen) Technology Limited, CN
JXG
Feb 2, 2023K222422Polaris Valve Electronic Reading Instrument
Sophysa, FR
JXG
Feb 1, 2023K223330Certas Plus Programmable Valves
Integra Lifesciences Production Corporation
JXG
Dec 29, 2022K223603Reflow System Mini and ReFlow Mini Flusher
Anuncia Medical, Inc.
JXG
Dec 8, 2022K222471IRRAflow Active Fluid Exchange System (AFES)
Irras USA
JXG
Oct 14, 2022K221840Hakim Programmable Valves, Hakim Precision Fixed Pressure Valves
Integra Lifesciences Production Corporation
JXG
Sep 29, 2022K221918ReFlow System Mini
Anuncia Medical, Inc.
JXG
Sep 16, 2021K212641StrataMR II Valves and Shunts
Medtronic Neurosurgery
JXG
May 8, 2020K200950Ventricular Catheter
Aesculap, Inc.
JXG
Apr 29, 2020K200807IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit
Irras USA, Inc.
JXG
Nov 21, 2019K192266M. Blue Adjustable Shunt System
Aesculap, Inc.
JXG
Nov 15, 2019K192289IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit
Irras USA, Ltd.
JXG
Oct 11, 2019K191684MoniTorr ICP External Drainage and Monitoring System, LimiTorr Volume Limiting External CSF Drainage System
Integra LifeSciences Corporation
JXG
Jul 5, 2019K190174Miethke Shunt System GAV 2.0 and SA 2.0 Valves
Aesculap, Inc.
JXG
Nov 20, 2018K182265CodMan Certas Plus Programmable Valve
Integra Lifesciences Corp.
JXG
Oct 25, 2018K181902Codman Certas Plus Electronic Tool Kit
Integra Lifesciences Corp.
JXG
Oct 1, 2018K181622StrataMR guider tool
Medtronic Neurosurgery
JXG
Jul 13, 2018K171880IRRAflow CNS System
Irras, Inc.
JXG
Jun 14, 2018K181301Smart External Drain (SED) System
Aqueduct Critical Care, Inc.
JXG
Mar 24, 2018K172035EKOS ultrasound EVD Device, EVD Control Unit
Btg International, Inc.
JXG
Nov 14, 2017K172759Smart External Drain (SED) System
Aqueduct Critical Care, Inc.
JXG
Nov 9, 2017K172006Alivio Ventricular Catheter and Flusher System (Alivio System)
Alcyone Lifesciences, Inc.
JXG
Oct 16, 2017K172537Codman EDS 3 CSF External Drainage System, Codman EDS 3 CSF External Drainage System Collection Bag
Codman & Shurtleff, Inc.
JXG
Oct 3, 2017K172022CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled)
Codman & Shurtleff, Inc.
JXG
Aug 31, 2017K170599SureFlo EVD Catheter
Arkis Biosciences, Inc.
JXG
Jun 30, 2017K171586Smart External Drain (SED) System
Aqueduct Critical Care, Inc.
JXG
Feb 27, 2017K161853proGAV Programmable Shunt System, proGAV 2.0 Adjustable Shunt System, proSA Adjustable Shunt System
Aesculap, Inc.
JXG
Oct 28, 2016K162437Codman EDS3 CSF External Drainage System
Codman & Shurtleff, Inc.
JXG
Oct 27, 2016K161605Smart External Drain (SED) System
Aqueduct Critical Care, Inc.
JXG
Sep 22, 2016K161992Horizontal-Vertical Lumbar Valve Systems, Spetzler Lumbar Peritoneal Shunt Systems
Integra LifeSciences Corporation
JXG
Apr 7, 2016K152700StrataMR Valves and Shunts
Medtronic Neurosurgery
JXG
Mar 14, 2016K153041Bundled Neurological Shunts and Accessories Product Families Labeling Modification to Support MR Conditional Labeling
Integra LifeSciences Corporation
JXG
Mar 4, 2016K152897Integra DP Valve Systems (including Burr Hole Reservoirs and Stainless Steel Connectors), Gravity Compensating Accessory
Integra LifeSciences Corporation
JXG
Dec 18, 2015K150898LiquoGuard 7, LiquoGuard 7 Drainage Set, Lenght 2000mm
Moller Medical GmbH, DE
JXG
Oct 27, 2015K152152Codman Certas Plus Programmable Valve
Medos International SARL, CH
JXG

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