The following data is part of a premarket notification filed by Cook Incorporated with the FDA for Cone Tip Ureteral Catheter, Rutner Universal Wedge Catheter.
| Device ID | K171810 |
| 510k Number | K171810 |
| Device Name: | Cone Tip Ureteral Catheter, Rutner Universal Wedge Catheter |
| Classification | Catheter, Urological |
| Applicant | Cook Incorporated 750 Daniels Way P.O. Box 489 Bloomington, IN 47402 |
| Contact | Yan Li |
| Correspondent | Yan Li Cook Incorporated 750 Daniels Way P.O. Box 489 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 | 2017-06-19 |
| Decision Date | 2018-03-07 |
| Summary: | summary |