K954164 is an FDA 510(k) clearance for the HYSTEROSCOPE, a Hysteroscope (and Accessories) (Class II — Special Controls, product code HIH), submitted by Conceptus, Inc. (San Carlos, US). The FDA issued a Cleared decision on March 12, 1996, 189 days after receiving the submission on September 5, 1995. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.1690.
| 510(k) Number | K954164 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 05, 1995 |
| Decision Date | March 12, 1996 |
| Days to Decision | 189 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | HIH — Hysteroscope (and Accessories) |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 884.1690 |