K926527 is an FDA 510(k) clearance for the ROTO FIT BIOPSY FORCEPS. This device is classified as a Forceps, Biopsy, Gynecological (Class I - General Controls, product code HFB).
Submitted by Thomasville Medical Assoc. (Alpharetta, US). The FDA issued a Cleared decision on February 25, 1994, 422 days after receiving the submission on December 30, 1992.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.4530.
| 510(k) Number | K926527 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 30, 1992 |
| Decision Date | February 25, 1994 |
| Days to Decision | 422 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Statement |
| Product Code | HFB — Forceps, Biopsy, Gynecological |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 884.4530 |