K881160 is an FDA 510(k) clearance for the CRANK FRAME RETRACTOR. This device is classified as a Retractor, Self-retaining, For Neurosurgery (Class II - Special Controls, product code GZT).
Submitted by T. Korossurgical Instruments Corp. (Moorepark, US). The FDA issued a Cleared decision on April 6, 1988, 19 days after receiving the submission on March 18, 1988.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4800.
| 510(k) Number | K881160 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 18, 1988 |
| Decision Date | April 06, 1988 |
| Days to Decision | 19 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | — |
| Product Code | GZT — Retractor, Self-retaining, For Neurosurgery |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.4800 |