K161065 is an FDA 510(k) clearance for the ColpoWave? Colpotomizer and CerviGrip? Uterine Manipulator, a Culdoscope (and Accessories) (Class II — Special Controls, product code HEW), submitted by Surgitools Pty , Ltd. (Woodvale, AU). The FDA issued a Cleared decision on October 27, 2016, 195 days after receiving the submission on April 15, 2016. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.1640.
| 510(k) Number | K161065 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 15, 2016 |
| Decision Date | October 27, 2016 |
| Days to Decision | 195 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 |