The following data is part of a premarket notification filed by Cook Incorporated with the FDA for Universa Firm Ureteral Stents And Stent Sets.
| Device ID | K161236 |
| 510k Number | K161236 |
| Device Name: | Universa Firm Ureteral Stents And Stent Sets |
| Classification | Stent, Ureteral |
| Applicant | COOK INCORPORATED 750 DANIELS WAY Bloomington, IN 47404 |
| Contact | Jamie Ridner |
| Correspondent | Jamie Ridner COOK INCORPORATED 750 DANIELS WAY Bloomington, IN 47404 |
| Product Code | FAD |
| CFR Regulation Number | 876.4620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-05-02 |
| Decision Date | 2017-01-27 |
| Summary: | summary |