The following data is part of a premarket notification filed by Cook Incorporated with the FDA for Bander Ureteral Diversion Stent Set, Dretler Ureteroscopy Stent Set.
| Device ID | K181971 |
| 510k Number | K181971 |
| Device Name: | Bander Ureteral Diversion Stent Set, Dretler Ureteroscopy Stent Set |
| Classification | Stent, Ureteral |
| Applicant | Cook Incorporated 750 Daniels Way Bloomington, IN 47404 |
| Contact | Paul Meyer |
| Correspondent | Paul Meyer Cook Incorporated 750 Daniels Way Bloomington, IN 47404 |
| Product Code | FAD |
| CFR Regulation Number | 876.4620 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-07-24 |
| Decision Date | 2019-04-23 |