The following data is part of a premarket notification filed by Urogen Pharma Ltd with the FDA for Urinary Catheter 12 Fr, Urinary Catheter 16 Fr.
| Device ID | K211032 |
| 510k Number | K211032 |
| Device Name: | Urinary Catheter 12 Fr, Urinary Catheter 16 Fr |
| Classification | Catheter, Urological |
| Applicant | UroGen Pharma Ltd 9 Ha'Ta'asiya Street Ra'anana, IL 4365405 |
| Contact | James G. Otinger |
| Correspondent | James G. Otinger UroGen Pharma Inc 400 Alexander Park Drive Princeton, NJ 08540 |
| Product Code | KOD |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-04-07 |
| Decision Date | 2021-11-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10854913006126 | K211032 | 000 |
| 20854913006116 | K211032 | 000 |