K201086 is an FDA 510(k) clearance for the Advincula Delineator Uterine Manipulator. This device is classified as a Culdoscope (and Accessories) (Class II - Special Controls, product code HEW).
Submitted by CooperSurgical, Inc. (Trumbull, US). The FDA issued a Cleared decision on May 21, 2020, 28 days after receiving the submission on April 23, 2020.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.1640.
| 510(k) Number | K201086 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 23, 2020 |
| Decision Date | May 21, 2020 |
| Days to Decision | 28 days |
| Submission Type | Special |
| 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 |