The following data is part of a premarket notification filed by Cook Incorporated with the FDA for Open-end Ureteral Catheter, Open-end Ureteral Catheter Sof-flex, Echotip Open-end Ureteral Catheter, Open-end Flexi-tip Ureteral Catheter, Flexi-tip Ureteral Catheter (closed End), Whistle Tip Ureteral Catheter, Round Tip Ureteral Catheter, Spiral Ti.
| Device ID | K171662 |
| 510k Number | K171662 |
| Device Name: | Open-End Ureteral Catheter, Open-End Ureteral Catheter Sof-Flex, EchoTip Open-End Ureteral Catheter, Open-End Flexi-Tip Ureteral Catheter, Flexi-Tip Ureteral Catheter (Closed End), Whistle Tip Ureteral Catheter, Round Tip Ureteral Catheter, Spiral Ti |
| Classification | Catheter, Urological |
| Applicant | Cook Incorporated 750 Daniels Way Bloomington, IN 47402 |
| Contact | Carly Powell |
| Correspondent | Carly Powell Cook Incorporated 750 Daniels Way Bloomington, IN 47402 |
| Product Code | KOD |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-06-05 |
| Decision Date | 2018-02-01 |
| Summary: | summary |