K992027 is an FDA 510(k) clearance for the KONINCKX UTERINE MANIPULATOR, KECKSTEIN-SCHIFF UTERINE MANIPULATOR, CLERMONT UTERINE MANIPULATOR, a Hysteroscope (and Accessories) (Class II — Special Controls, product code HIH), submitted by Karl Storz Endoscopy (Culver City, US). The FDA issued a Cleared decision on September 9, 1999, 85 days after receiving the submission on June 16, 1999. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.1690.
| 510(k) Number | K992027 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 16, 1999 |
| Decision Date | September 09, 1999 |
| Days to Decision | 85 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 |