The following data is part of a premarket notification filed by Coopersurgical, Inc. with the FDA for Endosee Hysteroscope With Disposable Diagnostic (dx) Cannula.
| Device ID | K170660 |
| 510k Number | K170660 |
| Device Name: | Endosee Hysteroscope With Disposable Diagnostic (Dx) Cannula |
| 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 | 2017-03-03 |
| Decision Date | 2017-07-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 60888937022485 | K170660 | 000 |
| 20888937022463 | K170660 | 000 |
| 00888937022452 | K170660 | 000 |