K941458 is an FDA 510(k) clearance for the UTERINE MANIPULATOR/INJECTOR WITH SPRING, a Cannula, Manipulator/injector, Uterine (Class II — Special Controls, product code LKF), submitted by Zinnanti Surgical Instruments, Inc. (Chatsworth, US). The FDA issued a Cleared decision on January 25, 1995, 306 days after receiving the submission on March 25, 1994. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4530.
| 510(k) Number | K941458 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 25, 1994 |
| Decision Date | January 25, 1995 |
| Days to Decision | 306 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | LKF — Cannula, Manipulator/injector, Uterine |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 884.4530 |