K974088 is an FDA 510(k) clearance for the CODMAN INTRACRANIAL BOLT. This device is classified as a Device, Monitoring, Intracranial Pressure (Class II - Special Controls, product code GWM).
Submitted by Johnson & Johnson Professionals, Inc. (Raynham, US). The FDA issued a Cleared decision on January 9, 1998, 71 days after receiving the submission on October 30, 1997.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1620.
| 510(k) Number | K974088 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 30, 1997 |
| Decision Date | January 09, 1998 |
| Days to Decision | 71 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | GWM — Device, Monitoring, Intracranial Pressure |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1620 |