K924224 is an FDA 510(k) clearance for the OWENS BIOPSY FORCEPS. This device is classified as a Forceps, Biopsy, Gynecological (Class I - General Controls, product code HFB).
Submitted by Owens Precision Systems, Inc. (Oak Creek, US). The FDA issued a Cleared decision on February 4, 1994, 532 days after receiving the submission on August 21, 1992.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.4530.
| 510(k) Number | K924224 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 21, 1992 |
| Decision Date | February 04, 1994 |
| Days to Decision | 532 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 |