K791765 is an FDA 510(k) clearance for the MASTERSON* ENDOMETRIAL BIOPSY KIT. This device is classified as a Curette, Suction, Endometrial (and Accessories) (Class II - Special Controls, product code HHK).
Submitted by Codman & Shurtleff, Inc. (Walker, US). The FDA issued a Cleared decision on November 5, 1979, 69 days after receiving the submission on August 28, 1979.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.1175.
| 510(k) Number | K791765 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 28, 1979 |
| Decision Date | November 05, 1979 |
| Days to Decision | 69 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | - |
| Product Code | HHK - Curette, Suction, Endometrial (and Accessories) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.1175 |