The following data is part of a premarket notification filed by Coopersurgical, Inc. with the FDA for Endosee System.
| Device ID | K183020 |
| 510k Number | K183020 |
| Device Name: | Endosee System |
| Classification | Hysteroscope (and Accessories) |
| Applicant | CooperSurgical, Inc. 95 Corporate Drive Trumbull, CT 06611 |
| Contact | Roaida Johnson |
| Correspondent | Roaida Johnson CooperSurgical, Inc. 95 Corporate Drive Trumbull, CT 06611 |
| Product Code | HIH |
| CFR Regulation Number | 884.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-11-01 |
| Decision Date | 2019-01-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00888937022018 | K183020 | 000 |