K897050 is an FDA 510(k) clearance for the WILSON-COOK LUNG BIOPSY NEEDLE. This device is classified as a Needle, Aspiration And Injection, Disposable (Class I - General Controls, product code GAA).
Submitted by Wilson-Cook Medical, Inc. (Winston-Salem, US). The FDA issued a Cleared decision on April 16, 1990, 119 days after receiving the submission on December 18, 1989.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K897050 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 18, 1989 |
| Decision Date | April 16, 1990 |
| Days to Decision | 119 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | GAA — Needle, Aspiration And Injection, Disposable |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4800 |