The following data is part of a premarket notification filed by Cook Incorporated with the FDA for Firlit-kluge Urethral Stent, Koyle Diaper Stent, Zaontz Urethral Stent.
| Device ID | K172278 |
| 510k Number | K172278 |
| Device Name: | Firlit-Kluge Urethral Stent, Koyle Diaper Stent, Zaontz Urethral Stent |
| Classification | Catheter, Urethral |
| Applicant | Cook Incorporated 750 Daniels Way Bloomington, IN 47404 |
| Contact | Samuel Engelman |
| Correspondent | Samuel Engelman Cook Incorporated 750 Daniels Way Bloomington, IN 47404 |
| Product Code | GBM |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-07-28 |
| Decision Date | 2017-11-22 |
| Summary: | summary |