K910656 is an FDA 510(k) clearance for the WILSON-COOK DISPOSABLE BIOPSY FORCEPS. This device is classified as a Station, Dialysis Control, Negative Pressure Type (Class II - Special Controls, product code FLC).
Submitted by Wilson-Cook Medical, Inc. (Winston-Salem, US). The FDA issued a Cleared decision on April 25, 1991, 70 days after receiving the submission on February 14, 1991.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5820.
| 510(k) Number | K910656 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 14, 1991 |
| Decision Date | April 25, 1991 |
| Days to Decision | 70 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
| Product Code | FLC — Station, Dialysis Control, Negative Pressure Type |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5820 |