Data / Medical devices / Switzerland / Integra LifeSciences Switzerland Sarl
Integra LifeSciences Switzerland Sarl: FDA-registered device maker in Le Locle Neuchatel, Switzerland, 43 510(k) clearances
Integra LifeSciences Switzerland Sarl is registered with the FDA (registration 3013886523) in Le Locle Neuchatel, Switzerland. It lists 6 device types. The FDA files 43 510(k) clearances under its listings, the newest dated June 23, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013886523
- Address
- Rue Girardet 29 Second Floor, Le Locle Neuchatel, Switzerland, Ch-2400
- Owner or operator
- Integra LifeSciences Corporation (9004007)
- Roles
- Manufacturer
- First device listed
- April 27, 1999
- Registered through
- 2026
- Brand names listed
- Alleghany CSF External Drainage Sys, Arkis Subcutaneous Guideware, Bactiseal Barium Striped Catheters, Bactiseal Catheters, Bactiseal Clear EVD Catheter Set, Bactiseal EVD Catheter Sets:, Bactiseal Endoscopic Ventricular Catheter, Braden Reservoir and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Ventricular | HCA | 2 | Manufacturer | accessdata.fda.gov |
| Device, Monitoring, Intracranial Pressure | GWM | 2 | Manufacturer | accessdata.fda.gov |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 2 | Manufacturer | accessdata.fda.gov |
| Instrument, Surgical, Non-Powered | HAO | 1 | Manufacturer | accessdata.fda.gov |
| Shunt, Central Nervous System And Components | JXG | 2 | Manufacturer | accessdata.fda.gov |
| Tray, Surgical, Instrument | FSM | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 23, 2026 | K261004 | Codman® Distal Peritoneal Catheter, Barium Open End (82-1682); Codman® HOLTER® Peritoneal Catheter (SALMON Design) (82-1684) | JXG | Substantially Equivalent | Integra Lifesciences Production Corporation | accessdata.fda.gov |
| January 17, 2024 | K233445 | Bactiseal Catheters; Bactiseal Barium Striped Catheters; Bactiseal Endoscopic Ventricular Catheter | JXG | Substantially Equivalent | Integra Lifesciences Production Corporation | accessdata.fda.gov |
| December 19, 2023 | K233448 | Bactiseal EVD Catheter Sets; Bactiseal Clear EVD Catheter Set | JXG | Substantially Equivalent | Integra Lifesciences Production Corporation | accessdata.fda.gov |
| February 1, 2023 | K223330 | Certas Plus Programmable Valves | JXG | Substantially Equivalent | Integra Lifesciences Production Corporation | accessdata.fda.gov |
| October 14, 2022 | K221840 | Hakim Programmable Valves, Hakim Precision Fixed Pressure Valves | JXG | Substantially Equivalent | Integra Lifesciences Production Corporation | accessdata.fda.gov |
| November 20, 2018 | K182265 | CodMan Certas Plus Programmable Valve | JXG | Substantially Equivalent | Integra Lifesciences Corp. | accessdata.fda.gov |
| November 8, 2017 | K173192 | CereLink ICP Sensor Basic Kit, CereLink ICP Sensor Metal Skull Bolt Kit, CereLink ICP Sensor Plastic Skull Bolt Kit, CereLink ICP Sensor Ventricular Catheter Kit | GWM | Substantially Equivalent | Codman & Shurtleff, Inc. | accessdata.fda.gov |
| October 16, 2017 | K172537 | Codman EDS 3 CSF External Drainage System, Codman EDS 3 CSF External Drainage System Collection Bag | JXG | Substantially Equivalent | Codman & Shurtleff, Inc. | accessdata.fda.gov |
| December 1, 2016 | K163106 | CODMAN Integrated Bipolar Cord and Tubing Set | GEI | Substantially Equivalent | Medos International SARL | accessdata.fda.gov |
| October 28, 2016 | K162437 | Codman EDS3 CSF External Drainage System | JXG | Substantially Equivalent | Codman & Shurtleff, Inc. | accessdata.fda.gov |
| October 26, 2016 | K162469 | CODMAN VersaTru Standard Disposable Non-Stick Bipolar Forceps, CODMAN VersaTru Slim Disposable Non-Stick Bipolar Forceps | GEI | Substantially Equivalent | Medos International SARL | accessdata.fda.gov |
| August 19, 2016 | K153347 | Codman Microsensor Basic Kit, Codman Microsensor Plastic Skull Bolt Kit, Codman Microsensor Ventricular Catheter Kit with Tuohy-Borst Adapter,Codman Microsensor Metal Skull Bolt Kit, Codman Microsensor Ventricular Catheter Kit | GWM | Substantially Equivalent | Codman & Shurtleff, Inc. | accessdata.fda.gov |
| January 22, 2016 | K152670 | DirectLink ICP Module, DirectLink ICP Extension Cable, Patient Monitor Interface Cables | GWM | Substantially Equivalent | Medos International SARL | accessdata.fda.gov |
| October 27, 2015 | K152152 | Codman Certas Plus Programmable Valve | JXG | Substantially Equivalent | Medos International SARL | accessdata.fda.gov |
| February 19, 2015 | K143111 | Codman Certas Plus Programmable Valve; Codman Certas Toll Kit | JXG | Substantially Equivalent | Medos International SARL | accessdata.fda.gov |
| January 6, 2015 | K140722 | INTEGRA FLOW REGULATING VALVE SYSTEMS OSV II MODELS AND INTEGRA FLOW REGULATING VALVE LOW FLOW MODELS | JXG | Substantially Equivalent | Integra LifeSciences Corporation | accessdata.fda.gov |
| August 3, 2012 | K122118 | HAKIM PROGRAMMABLE AND PRECISION VALVE SHUNT SYSTEM | JXG | Substantially Equivalent | Codman & Shurtleff, Inc. | accessdata.fda.gov |
| May 9, 2011 | K110751 | CODMAN BACTISEAL ENDOSCOPIC VENTICULAR CATHETER | JXG | Substantially Equivalent | Codman & Shurtleff, Inc. | accessdata.fda.gov |
| February 18, 2011 | K102961 | HOLTER IN-LINE SHUNT FILTER, HOLTER CEREBRAL CATHETER RESERVOIR, ACCU-FLO CONNECTORS; ACCU-FLO THREE WAY CONNECTOR; CODM | JXG | Substantially Equivalent | Codman & Shurtleff, Inc. | accessdata.fda.gov |
| January 14, 2011 | K102589 | CODMAN BACTISEAL CATHETERS, CODMAN BACTISEAL EVD CATHETER | JXG | Substantially Equivalent | Codman & Shurtleff, Inc. | accessdata.fda.gov |
| January 22, 2010 | K093968 | OSV II LOW FLOW LOW PRO VALVE | JXG | Substantially Equivalent | Integra LifeSciences Corporation | accessdata.fda.gov |
| November 19, 2009 | K092395 | OSV II LUMBAR VALVE SYSTEM AND OSV II LOW FLOW LUMBAR VALVE SYSTEM | JXG | Substantially Equivalent | Integra Lifesciences Corp. | accessdata.fda.gov |
| March 4, 2009 | K090348 | CODMAN BACTISEAL EVD CATHETER SET, CODMAN BACTISEAL CLEAR EVD CATHETER SET | JXG | Substantially Equivalent | Codman & Shurtleff, Inc. | accessdata.fda.gov |
| November 6, 2008 | K081773 | OSV II | JXG | Substantially Equivalent | Integra Neurosciences Implants S.A. | accessdata.fda.gov |
| October 16, 2006 | K061876 | CODMAN VPV SYSTEM, MODEL 82-3192 | JXG | Substantially Equivalent | Codman & Shurtleff, Inc. | accessdata.fda.gov |
| September 29, 2006 | K061568 | CODMAN EDS 3 CSF EXTERNAL DRAINAGE SYSTEM, MODELS 82-1730, 82-1731, 82-1732, 82-1733, 82-1735, 82-1738 | JXG | Substantially Equivalent | Codman & Shurtleff, Inc. | accessdata.fda.gov |
| May 10, 2006 | K053244 | LICOX IT2 COMPLETE BRAIN TUNNELING PROBE KIT | GWM | Substantially Equivalent | Integra Lifesciences Corp. | accessdata.fda.gov |
| January 19, 2006 | K053350 | MODIFICATION TO CODMAN HAKIM SHUNT SYSTEMS | JXG | Substantially Equivalent | Codman & Shurtleff, Inc. | accessdata.fda.gov |
| January 19, 2006 | K053107 | CODMAN HAKIM PROGRAMMABLE VALVE W/WO SIPHONGUARD | JXG | Substantially Equivalent | Codman & Shurtleff, Inc. | accessdata.fda.gov |
| September 2, 2004 | K042192 | LOW FLOW OSV II HYDROCEPHALUS VALVE | JXG | Substantially Equivalent | Integra Neurosciences Implants S.A. | accessdata.fda.gov |
| June 10, 2004 | K041296 | MODIFICATION TO HAKIM PRECISION VALVE SYSTEM, HAKIM PROGRAMMABLE VALVE SYSTEM, HAKIM MICRO PROGRAMMABLE VALVE SYSTEM, SI | JXG | Substantially Equivalent | Codman & Shurtleff, Inc. | accessdata.fda.gov |
| April 20, 2004 | K040235 | LICOX PMO BRAIN MONITORING SYSTEM | GWM | Substantially Equivalent | Integra LifeSciences Corporation | accessdata.fda.gov |
| May 14, 2003 | K031123 | CODMAN BACTISEAL BARIUM STRIPED CATHETERS | HCA | Substantially Equivalent | Codman & Shurtleff, Inc. | accessdata.fda.gov |
| July 29, 2002 | K021653 | CODMAN BACTISEAL EVD CATHETER SET | JXG | Substantially Equivalent | Codman & Shurtleff, Inc. | accessdata.fda.gov |
| March 28, 2002 | K020667 | CODMAN HAKIM SHUNT SYSTEMS | JXG | Substantially Equivalent | Codman & Shurtleff, Inc. | accessdata.fda.gov |
| October 1, 2001 | K003322 | CODMAN BACTISEAL CATHETERS | HCA | Substantially Equivalent | Codman & Shurtleff, Inc. | accessdata.fda.gov |
| December 20, 2000 | K003564 | HAKIM PROGRAMMER AND TRANSMITTER | JXG | Substantially Equivalent | Codman & Shurtleff, Inc. | accessdata.fda.gov |
| November 24, 2000 | K002765 | LICOX CMP MONITOR-AC3.1, LICOX IMC OXYGEN CATHETERS-CC1,CC1.SB LUICOX IMC INTRODUCER KITS-IM,IM2,IM3,II1 LICOXIMC TEMPE | GWM | Substantially Equivalent | Integra Neurosciences | accessdata.fda.gov |
| April 7, 2000 | K992173 | SIPHONGUARD CSF CONTROL DEVICE | JXG | Substantially Equivalent | Johnson & Johnson Professionals, Inc. | accessdata.fda.gov |
| January 9, 1998 | K974088 | CODMAN INTRACRANIAL BOLT | GWM | Substantially Equivalent | Johnson & Johnson Professionals, Inc. | accessdata.fda.gov |
| December 29, 1997 | K973774 | CODMAN HAKIM MICRO PRECISION VALVE | JXG | Substantially Equivalent | Johnson & Johnson Professionals, Inc. | accessdata.fda.gov |
| July 28, 1995 | K944222 | CODMAN-MEDOS VALVE SHUNT SYSTEM | JXG | Substantially Equivalent | Johnson & Johnson Professionals, Inc. | accessdata.fda.gov |
| March 7, 1994 | K914479 | MICROSENSOR INTRACRANIAL PRESSURE TRANSDUCER | GWM | Substantially Equivalent | Codman & Shurtleff, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Tray, Surgical, Instrument
- All makers of Electrosurgical, Cutting & Coagulation & Accessories
- All makers of Shunt, Central Nervous System And Components
- All makers of Device, Monitoring, Intracranial Pressure
- All makers of Instrument, Surgical, Non-Powered
- All makers of Catheter, Ventricular
Updated June 23, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.