The following data is part of a premarket notification filed by Cook Incorporated with the FDA for Uvue Hsg/shg Catheter.
| Device ID | K160217 |
| 510k Number | K160217 |
| Device Name: | UVue HSG/SHG Catheter |
| Classification | Cannula, Manipulator/injector, Uterine |
| Applicant | COOK INCORPORATED 750 DANIELS WAY Bloomington, IN 47404 |
| Contact | Kara Kanorr |
| Correspondent | Kara Kanorr COOK INCORPORATED 750 DANIELS WAY Bloomington, IN 47404 |
| Product Code | LKF |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-01-29 |
| Decision Date | 2016-10-06 |
| Summary: | summary |