K911772 is an FDA 510(k) clearance for the GARDNER PINS (ADULT & CHILD). This device is classified as a Holder, Head, Neurosurgical (skull Clamp) (Class II - Special Controls, product code HBL).
Submitted by Codman & Shurtleff, Inc. (Randolph, US). The FDA issued a Cleared decision on August 26, 1991, 129 days after receiving the submission on April 19, 1991.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4460.
| 510(k) Number | K911772 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 19, 1991 |
| Decision Date | August 26, 1991 |
| Days to Decision | 129 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Statement |
| Product Code | HBL - Holder, Head, Neurosurgical (skull Clamp) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.4460 |