The following data is part of a premarket notification filed by Cooper Surgical Inc. with the FDA for Coopersurgical Advincula Delineator Uterine Manipulator.
| Device ID | K143650 |
| 510k Number | K143650 |
| Device Name: | CooperSurgical Advincula Delineator Uterine Manipulator |
| Classification | Culdoscope (and Accessories) |
| Applicant | Cooper Surgical Inc. 95 Corporate Drive Trumbull, CT 06611 |
| Contact | James Keller |
| Correspondent | Tim M Lohnes Orchid Design 80 Shelton Technology Center Shelton, CT 06484 |
| Product Code | HEW |
| CFR Regulation Number | 884.1640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-12-23 |
| Decision Date | 2015-07-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20888937013812 | K143650 | 000 |
| 00888937013801 | K143650 | 000 |
| 20888937012792 | K143650 | 000 |
| 20888937012785 | K143650 | 000 |
| 20888937012778 | K143650 | 000 |
| 20888937012754 | K143650 | 000 |
| 20888937012747 | K143650 | 000 |