510(k) K914479 ยท GWM Device, Monitoring, Intracranial Pressure
MICROSENSOR INTRACRANIAL PRESSURE TRANSDUCER
| Applicant | Codman & Shurtleff, Inc., Randolph MA, US |
| Decision | Substantially Equivalent, Mar 7, 1994 |
| Received | Oct 8, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K914479
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.