K971315 is an FDA 510(k) clearance for the AUXILIARY INSTRUMENTS FOR URS, a Forceps, Biopsy, Non-electric (Class I — General Controls, product code FCL), submitted by Richard Wolf Medical Instruments Corp. (Vernon Hills, US). The FDA issued a Cleared decision on September 15, 1997, 159 days after receiving the submission on April 9, 1997. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1075.
| 510(k) Number | K971315 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 09, 1997 |
| Decision Date | September 15, 1997 |
| Days to Decision | 159 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FCL — Forceps, Biopsy, Non-electric |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 876.1075 |