K111014 is an FDA 510(k) clearance for the LSI SOLUTIONS FORNISEE SYSTEM UTERINE MANIPULATOR AND ACCESSORIES. This device is classified as a Culdoscope (and Accessories) (Class II - Special Controls, product code HEW).
Submitted by Lsi Solutions, Inc. (Victor, US). The FDA issued a Cleared decision on July 13, 2012, 459 days after receiving the submission on April 11, 2011.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.1640.
| 510(k) Number | K111014 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 11, 2011 |
| Decision Date | July 13, 2012 |
| Days to Decision | 459 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | HEW - Culdoscope (and Accessories) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.1640 |