K974312 is an FDA 510(k) clearance for the REUSABLE BIOPSY FORCEPS OVAL CUP, REUSABLE BIOSY FORCEPS OVAL CUP W/NEEDLE, REUSABLE BIOPSY FORCEPS SERRATED CUP, REUSAR. This device is classified as a Instrument, Biopsy (Class II - Special Controls, product code KNW).
Submitted by Telemed Systems, Inc. (Marlborough, US). The FDA issued a Cleared decision on January 21, 1998, 65 days after receiving the submission on November 17, 1997.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1075.
| 510(k) Number | K974312 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 17, 1997 |
| Decision Date | January 21, 1998 |
| Days to Decision | 65 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | KNW — Instrument, Biopsy |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1075 |