Device, Monitoring, Intracranial Pressure
Regulation 882.1620
1510(k)s in 12 months (105 all time)
3recalls in 12 months (52 all time)
47recalls that name a 510(k)
Top companies in GWM
| Company | 510(k)s | Recalls |
|---|---|---|
| Integra LifeSciences Corporation | 8 | 26 |
| Codman & Shurtleff, Inc. | 9 | 12 |
| Innerspace, Inc. | 7 | 0 |
| Raumedic AG | 6 | 0 |
| Sophysa | 3 | 3 |
| Integra Neurosciences | 5 | 0 |
| Metatech Corp. | 5 | 0 |
| Camino Laboratories, Inc. | 4 | 0 |
| Cma Microdialysis AB | 4 | 0 |
| Camino Neurocare, Inc. | 3 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 8, 2026 | Integra LifeSciences Corp. (NeuroSciences) Codman CereLink ICP Sensor Basic Kit. Catalog Number: 826850.
The Codman CereLink ICP Sensor Basic Kit consists of the CereLink ICP Sensor (ICP Sensor) and a 14-gauge Tuohy needle with stylet. The I Open, Classified |
GWM | K173192 |
| Jan 8, 2026 | Integra LifeSciences Corp. (NeuroSciences) Codman Microsensor Basic Kit. Catalog Number: 626631US.
Use of the CODMAN MICROSENSOR Basic Kit is indicated when direct ICP monitoring is required. The kit is indicated for use in both subdural and Open, Classified |
GWM | K153347 |
| Jan 8, 2026 | Sophysa The Pressio 2 ICP Monitoring System, Model Number PSO-4000; Intracranial Pressure Monitor Open, Classified |
GWM | K162108 |
| 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 |
| Oct 23, 2024 | Smiths Medical ASD, Inc. medex TranStar Single ICP Set 1/EA, Product Code REF MX20897 Open, Classified |
GWM | K020780 |
| Oct 23, 2024 | Smiths Medical ASD, Inc. medex TranStar Single OR Set 1/EA, Product Code REF MX20846R2 Open, Classified |
GWM | K020780 |
| May 15, 2024 | Sophysa S.A. The Sophysa Pressio Ventricular Intracranial Pressure Monitoring Kit monitoring is intended for monitoring intracranial ventricular pressure and temperature with tunneling (PSO-VTT) indicated for use Open, Classified |
GWM | K062584 K162108 |
| May 15, 2024 | Sophysa S.A. The Sophysa Pressio Ventricular Intracranial Pressure Monitoring Kit monitoring is intended for monitoring intracranial ventricular pressure with tunneling (PSO-VT) indicated for use in intraventricul Open, Classified |
GWM | K062584 K162108 |
| Dec 14, 2023 | Integra LifeSciences Corp. CereLink ICP Extension Cable (Extension Cable), Model No. 826845
Used with Codman CereLink Intracranial Pressure (ICP) Monitor, Model No. 826820/826820P. Cable is also provided with monitor as part o Open, Classified |
GWM | K210993 K232890 |
| May 19, 2023 | Integra LifeSciences Corp. Codman Cranial Hand Drill- Indicated when a craniotomy is required for placement of an intracranial pressure (ICP) monitoring device and/or cerebrospinal fluid drainage device.
Part Number: 82-6607 Open, Classified |
GWM | K914479 |
| Jul 22, 2022 | Integra LifeSciences Corp. CereLink ICP Monitor; Catalog No. 826820, 826820P. Intracranial pressure monitor. Open, Classified |
GWM | K210993 |
| Sep 12, 2019 | Integra LifeSciences Corp. Cerelink ICP Monitor, Model Number 826820; intended for use as an interface between compatible strain-gauge type pressure transducers and standard physiological pressure monitoring systems. Open, Classified |
GWM | K183406 |
| Jun 18, 2015 | Integra LifeSciences Corp. Integra Camino Intracranial Pressure Monitoring Catheter with Licox IMC Bolt Fitting, Catalog No. 110-4L
The Camino Intracranial Pressure Monitoring Catheter is a sterile transducer-tipped pressure mo Terminated |
GWM | K102875 |
| May 15, 2015 | Integra LifeSciences Corp. The Integra Licox Pt02 Monitors are compact, portable device for use with Pressure/Temperature, Pressure and Oxygen Partial Pressure Transducer-Tipped Catheters.
The LCX02R monitor measures and displ Terminated |
GWM | K121573 K131184 |
| May 15, 2015 | Integra LifeSciences Corp. The Integra Licox Pt02 Monitors are compact, portable device for use with Pressure/Temperature, Pressure and Oxygen Partial Pressure Transducer-Tipped Catheters.
The LCX02 monitor measures and displa Terminated |
GWM | K121573 K131184 |
| May 15, 2015 | Integra LifeSciences Corp. The Integra Camino ICP Monitor is a compact, portable device for use with Pressure/Temperature, Pressure and Oxygen Partial Pressure Transducer-Tipped Catheters.
The CAM02 monitor measures and displa Terminated |
GWM | K121573 K131184 |
| Dec 18, 2014 | Integra LifeSciences Corp. Integra Licox Brain Tissue Oxygen Monitoring
Integra Licox Recon Tissue Oxygen Monitoring
1) LICOX Complete Brain Probe Kit (comprised of IP1, CC1.P1)
2) LICOX Complete Brain Probe Kit (comprised of Terminated |
GWM | K002765 K040235 +1 |
| Nov 10, 2014 | Integra LifeSciences Corp. Integra Licox Pt02 Monitor, Rx Only, Manufacturer: Integra LifeSciences (Ireland) Limited, IDA Business and Technology Park, Sragh, Tullamore, County Offaly, Ireland, Distributed by: Integra LifeScien Terminated |
GWM | K131184 |
| May 30, 2014 | Integra LifeSciences Corp. Integra Licox Test Kit REF BC10R Rx Only
An accessory provided for use with the LCXO2 and AC31 PtO2 Monitors. It provides users with a secondary means to verify the monitor's PtO2 state-of-calibrati Terminated |
GWM | K131184 |
| Dec 27, 2013 | Integra LifeSciences Corp. Integra Camino Advanced Monitor with Waveform Display Model CAM01 Integra Neurosciences, 311 Enterprise Dr Plainsboro, NJ 08536 USA
The Camino Advanced Monitor is a compact, portable device for use w Terminated |
GWM | K962928 |
| Oct 30, 2013 | Integra Limited Brand Names: Integra Camino 110-4 Intracranial Pressure (ICP) Monitoring
Catheters.
Product / Catalogue No.s: 110-4B, 110-4BC, 110-4G, 110-4H, 110-4HC, 110-4L, 110-4LC.
The fully packaged 110-4B, 110- Terminated |
GWM | K102875 |
| Oct 23, 2013 | Integra LifeSciences Corp. Integra Licox Brain Tissue Oxygen Monitoring
1 x Complete Brain Probe Kit
REF IM3.ST_.EU
Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Ge Terminated |
GWM | K040235 |
| Oct 23, 2013 | Integra LifeSciences Corp. Integra Licox Brain Tissue Oxygen Monitoring
1 x Complete Brain Probe Kit
REF IM3.S_.EU
Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Ger Terminated |
GWM | K040235 |
| Oct 23, 2013 | Integra LifeSciences Corp. Integra Licox Brain Tissue Oxygen Monitoring
1 x Dual Lumen Introducer Kit
REF IM2.S_.EU
Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Ge Terminated |
GWM | K040235 |
| Oct 23, 2013 | Integra LifeSciences Corp. Integra Licox Brain Tissue Oxygen Monitoring
1 x Dual Lumen Introducer Kit
REF IM2_EU
Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germa Terminated |
GWM | K040235 |
| Oct 23, 2013 | Integra LifeSciences Corp. Integra Licox Brain Tissue Oxygen Monitoring
1 x Complete Brain Probe Kit
REF IM1.S
Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germa Terminated |
GWM | K040235 |
| Oct 23, 2013 | Integra LifeSciences Corp. Integra Licox Brain Tissue Oxygen Monitoring
1 x Complete Brain Probe Kit
REF IM3.SR
Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germ Terminated |
GWM | None listed |
| Oct 23, 2013 | Integra LifeSciences Corp. Inegra Licox Brain Tissue Oxygen Monitoring
1 x Complete Brain Tunneling Probe Kit
REF IT2
Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Terminated |
GWM | K040235 |
| Oct 23, 2013 | Integra LifeSciences Corp. Integra Licox Brain Tissue Oxygen Monitoring
1 x Complete Brain Probe Kit
REF IP2.P
Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany Terminated |
GWM | K040235 |
| Oct 23, 2013 | Integra LifeSciences Corp. Integra Licox Brain Tissue Oxygen Monitoring; 1 x Dual Lumen Introducer Kit
REF IP2; Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany Terminated |
GWM | K040235 |
| Oct 23, 2013 | Integra LifeSciences Corp. Integra Licox Brain Tissue Oxygen Monitoring; 1 x Complete Brain Probe Kit
REF IP1.P
Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany Terminated |
GWM | K040235 |
| Mar 22, 2012 | Codman & Shurtleff, Inc. Codman ICP Skull Bolt Kit, Product Code: 82-6638. Single Use, disposable drill kit for gaining access to the cranium to allow for insertion and retention of intracranial cranial pressure sensor, inclu Terminated |
GWM | K974088 |
| Feb 3, 2012 | Integra LifeSciences Corp Integra PAC1 Mod 2 Cables used with the Integra MPM, CAM01 Monitors Terminated |
GWM | K962928 |
| Jan 11, 2012 | Codman & Shurtleff, Inc. Codman Cranial Disposable Intracranial Pressure (ICP) Kit, Plastic Subarachnoid Screw, Pediatric
Product Code:80-1197
Product Usage:
The Codman Cranial Access and ICP Kits are convenience kits whic Terminated |
GWM | K853770 |
| Jan 11, 2012 | Codman & Shurtleff, Inc. Codman Cranial Disposable Intracranial Pressure (ICP) Kit, Plastic Subarachnoid Screw,, Adult
Product Code:80-1196
Product Usage:
The Codman Cranial Access and ICP Kits are convenience kits which pr Terminated |
GWM | K853770 |
| Jan 11, 2012 | Codman & Shurtleff, Inc. Codman Cranial Disposable Intracranial Pressure (ICP) Kit, Stainless Steel Subarachnoid Screw
Product Code:80-1190
Product Usage:
The Codman Cranial Access and ICP Kits are convenience kits which pr Terminated |
GWM | K853770 |
| Jan 11, 2012 | Codman & Shurtleff, Inc. Codman Cranial Access Kit - complete with Xylocaine
Product Code: 82-6614
Product Usage:
The Codman Cranial Access and ICP Kits are convenience kits which provide devices and the drug (Xylocaine) t Terminated |
GWM | K914479 |
| Jan 11, 2012 | Codman & Shurtleff, Inc. Codman Cranial Access Kit with Xylocaine
Product Code: 82-6612
Product Usage:
The Codman Cranial Access and ICP Kits are convenience kits which provide devices and the drug (Xylocaine) to allow ph Terminated |
GWM | K914479 |
| Apr 20, 2011 | Codman & Shurtleff, Inc. Codman Plastic Disposable ICP Kit, Complete, Adult Product Code 80-1197
This is a single use, disposable drill kit designed for gaining access to the cranium for therapeutic and/or diagnostic procedu Terminated |
GWM | None listed |
| Apr 20, 2011 | Codman & Shurtleff, Inc. Codman Cranial Hand Drill
Product Code: 82-6607
This is a single use, disposable drill kit designed for gaining access to the cranium for therapeutic and/or diagnostic procedures Terminated |
GWM | None listed |
| Apr 20, 2011 | Codman & Shurtleff, Inc. Codman Plastic Disposable ICP Kit, Adult
Product Code: 80-1196
This is a single use, disposable drill kit designed for gaining access to the cranium for therapeutic and/or diagnostic procedures Terminated |
GWM | K853770 |
| Apr 20, 2011 | Codman & Shurtleff, Inc. Codman Metal Disposable ICP Kit
Product Code: 80-1190
This is a single use, disposable drill kit designed for gaining access to the cranium for therapeutic and/or diagnostic procedures Terminated |
GWM | None listed |
| Apr 20, 2011 | Codman & Shurtleff, Inc. Ghajar Guide Ventriculostomy Kit
Product Code: 80-1185
This is a single use, disposable drill kit designed for gaining access to the cranium for therapeutic and/or diagnostic procedures Terminated |
GWM | K853770 |
| Apr 20, 2011 | Codman & Shurtleff, Inc. Codman Disposable Twist Drill
Product code: 80-1200
This is a single use, disposable drill kit designed for gaining access to the cranium for therapeutic and/or diagnostic procedures Terminated |
GWM | None listed |
| Mar 3, 2011 | Integra LifeSciences Corp. LICOX CMP Tissue Oxygen Monitor; Catalog numbers REF AC31. Manufacturer GMS Gesellschaft fur medizinische, Sondentechnik mbH, Dorfstrasse 2, 24247 Mielkendorf, Germany; Distributed by Integra NeuroSc Terminated |
GWM | K002765 |
| Oct 28, 2010 | Integra LifeSciences Corp. Licox Brain PMO Probe Kit;
Ref IP2.P;
Multiparameter Monitoring Oxygen + ICP Channel: Contain Products: REF IP2 Bolt kit for 2 brain probes, Ref CC1.P1 combined Oxygen & Temperature probe;
Contains st Terminated |
GWM | K040235 |
| Apr 20, 2010 | Integra LifeSciences Corp. Integra, Licox Ref 1P2.P;
Brain PMO-Probe Kit
Rx only; Contains Products: REF 1P2 Bolt kit for 2 Brain probes,
REF CC1/P1 Combined Oxygen & Temperature Probe.
Contents Sterile and Non-Pyrogenic if pa Terminated |
GWM | K040235 |
| Dec 29, 2009 | Spiegelberg Gmbh & Co. KG Spiegelberg Brain Pressure Monitoring System
Probe 3PN, REF: SNDI3.1.531FV534P and Probe 3PS, REF: SNDI3.1.63/FV535P
Product Usage: lntracranial pressure measuring probes are used to measure intracr Terminated |
GWM | K003759 |
| Aug 5, 2008 | Integra Neuro Sciences INTEGRA NeuroSensor Probe, REF NS-P, component of Cerebral Blood Flow and Intracranial Pressure Monitoring Kit, Integra NeuroSciences Terminated |
GWM | K071505 |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.