The following data is part of a premarket notification filed by Coopersurgical, Inc. with the FDA for Advincula Delineator Uterine Manipulator.
| Device ID | K180429 |
| 510k Number | K180429 |
| Device Name: | Advincula Delineator Uterine Manipulator |
| Classification | Culdoscope (and Accessories) |
| Applicant | CooperSurgical, Inc. 95 Corporate Dr Trumbull, CT 06611 |
| Contact | Roaida Johnson |
| Correspondent | Roaida Johnson CooperSurgical, Inc. 95 Corporate Dr 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 | 2018-02-16 |
| Decision Date | 2018-03-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20888937021374 | K180429 | 000 |
| 20888937021367 | K180429 | 000 |
| 20888937021350 | K180429 | 000 |
| 20888937021343 | K180429 | 000 |