K911155 is an FDA 510(k) clearance for the OVAL CUP BIOPSY FORCEP. This device is classified as a Instrument, Biopsy, Mechanical, Gastrointestinal (Class II - Special Controls, product code FCF).
Submitted by Endovations (Mechanicsburg, US). The FDA issued a Cleared decision on August 7, 1991, 145 days after receiving the submission on March 15, 1991.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1075.
| 510(k) Number | K911155 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 15, 1991 |
| Decision Date | August 07, 1991 |
| Days to Decision | 145 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
| Product Code | FCF — Instrument, Biopsy, Mechanical, Gastrointestinal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1075 |