The following data is part of a premarket notification filed by Urogen Pharma Ltd. with the FDA for Uroject12 Syringe Lever.
| Device ID | K180345 |
| 510k Number | K180345 |
| Device Name: | Uroject12 Syringe Lever |
| Classification | Syringe, Piston |
| Applicant | UroGen Pharma Ltd. 9 Ha`Ta`asiya Street Ra’anana, IL 4365007 |
| Contact | Liz Schindel |
| Correspondent | James G Ottinger UroGen Pharma Ltd. 499 Park Avenue, 12th Floor, Suite 1200 New York, NY 10022 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-02-08 |
| Decision Date | 2018-10-17 |
| Summary: | summary |