K992591 is an FDA 510(k) clearance for the CODMAN SINGLE AND DOUBLE LUMEN SKULL BOLT KITS. This device is classified as a Device, Monitoring, Intracranial Pressure (Class II - Special Controls, product code GWM).
Submitted by Codman & Shurtleff, Inc. (Raynham, US). The FDA issued a Cleared decision on October 15, 1999, 74 days after receiving the submission on August 2, 1999.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1620.
| 510(k) Number | K992591 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 02, 1999 |
| Decision Date | October 15, 1999 |
| Days to Decision | 74 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 |