K954097 is an FDA 510(k) clearance for the SELECTCELLS STANDARD, a Curette, Suction, Endometrial (and Accessories) (Class II — Special Controls, product code HHK), submitted by Select Medical Systems, Inc. (Williston, US). The FDA issued a Cleared decision on November 21, 1995, 82 days after receiving the submission on August 31, 1995. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.1175.
| 510(k) Number | K954097 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 31, 1995 |
| Decision Date | November 21, 1995 |
| Days to Decision | 82 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | HHK — Curette, Suction, Endometrial (and Accessories) |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 884.1175 |