510(k) K853770 ยท GWM Device, Monitoring, Intracranial Pressure
CODMAN DISPOSABLE PLASTIC INTRACRANIAL PRESS/KIT
| Applicant | Codman & Shurtleff, Inc., Randolph MA, US |
| Decision | Substantially Equivalent, Oct 6, 1986 |
| Received | Sep 9, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K853770
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 | None listed |
| 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 | None listed |
| 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 | 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 | 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 | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.