K071338 is an FDA 510(k) clearance for the FLEX ARM RETRACTOR SYSTEM. This device is classified as a Retractor, Self-retaining, For Neurosurgery (Class II - Special Controls, product code GZT).
Submitted by Koros USA, Inc. (Moorepark, US). The FDA issued a Cleared decision on May 29, 2007, 15 days after receiving the submission on May 14, 2007.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4800.
| 510(k) Number | K071338 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 14, 2007 |
| Decision Date | May 29, 2007 |
| Days to Decision | 15 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 |