K990231 is an FDA 510(k) clearance for the WILTEK HOT BIOPSY FORCEPS, a Forceps, Biopsy, Electric (Class II — Special Controls, product code KGE), submitted by Wiltek Medical, Inc. (Winston-Salem, US). The FDA issued a Cleared decision on April 13, 1999, 78 days after receiving the submission on January 25, 1999. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.4300.
| 510(k) Number | K990231 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 25, 1999 |
| Decision Date | April 13, 1999 |
| Days to Decision | 78 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | KGE — Forceps, Biopsy, Electric |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.4300 |