K902693 is an FDA 510(k) clearance for the WALLACH FLEXIBLE ENDOMETRIAL SAMPLER. This device is classified as a Aspirator, Endometrial (Class II - Special Controls, product code HFF).
Submitted by Wallach Surgical Devices, Inc. (Milford, US). The FDA issued a Cleared decision on January 31, 1991, 226 days after receiving the submission on June 19, 1990.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.1060.
| 510(k) Number | K902693 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 19, 1990 |
| Decision Date | January 31, 1991 |
| Days to Decision | 226 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | — |
| Product Code | HFF — Aspirator, Endometrial |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.1060 |