K913233 is an FDA 510(k) clearance for the CODMAN LHALO SPLIT RING RETRACTOR SYSTEM. This device is classified as a Retractor, Self-retaining, For Neurosurgery (Class II - Special Controls, product code GZT).
Submitted by Codman & Shurtleff, Inc. (Randolph, US). The FDA issued a Cleared decision on July 31, 1991, 9 days after receiving the submission on July 22, 1991.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4800.
| 510(k) Number | K913233 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 22, 1991 |
| Decision Date | July 31, 1991 |
| Days to Decision | 9 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Statement |
| Product Code | GZT - Retractor, Self-retaining, For Neurosurgery |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.4800 |