510(k) K153347 ยท GWM Device, Monitoring, Intracranial Pressure
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
| Applicant | Codman & Shurtleff, Inc., Raynham MA, US |
| Decision | Substantially Equivalent, Aug 19, 2016 |
| Received | Nov 20, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K153347
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.