K895900 is an FDA 510(k) clearance for the WILSON-COOK BILIARY AND GASTRIC ASPIRATION NEEDLE. This device is classified as a Instrument, Biopsy, Suction (Class II - Special Controls, product code FCK).
Submitted by Wilson-Cook Medical, Inc. (Winston-Salem, US). The FDA issued a Cleared decision on January 11, 1990, 97 days after receiving the submission on October 6, 1989.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1075.
| 510(k) Number | K895900 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 06, 1989 |
| Decision Date | January 11, 1990 |
| Days to Decision | 97 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
| Product Code | FCK — Instrument, Biopsy, Suction |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1075 |