K060097 is an FDA 510(k) clearance for the GROSSMAN SELF-RETAINING LOW PROFILE BRAIN RETRACTOR, MODEL 04-001-00. This device is classified as a Retractor, Self-retaining, For Neurosurgery (Class II - Special Controls, product code GZT).
Submitted by KLS-Martin L.P. (Jacksonville, US). The FDA issued a Cleared decision on February 27, 2006, 45 days after receiving the submission on January 13, 2006.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4800.
| 510(k) Number | K060097 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 13, 2006 |
| Decision Date | February 27, 2006 |
| Days to Decision | 45 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | GZT — Retractor, Self-retaining, For Neurosurgery |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.4800 |