The following data is part of a premarket notification filed by Coopersurgical, Inc. with the FDA for Advincula Delineator Uterine Manipulator.
| Device ID | K201086 |
| 510k Number | K201086 |
| Device Name: | Advincula Delineator Uterine Manipulator |
| Classification | Culdoscope (and Accessories) |
| Applicant | CooperSurgical, Inc. 95 Corporate Drive Trumbull, CT 06611 |
| Contact | Kyle Hooper |
| Correspondent | Kyle Hooper CooperSurgical, Inc. 95 Corporate Drive Trumbull, CT 06611 |
| Product Code | HEW |
| CFR Regulation Number | 884.1640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-04-23 |
| Decision Date | 2020-05-21 |