Data / Medical devices / Israel / Urogen Pharma Ltd.
Urogen Pharma Ltd.: FDA-registered device maker in Ra'anana Central, Israel, 3 510(k) clearances
Urogen Pharma Ltd. is registered with the FDA (registration 3013024191) in Ra'anana Central, Israel. It lists 6 device types. The FDA files 3 510(k) clearances under its listings, the newest dated November 19, 2021. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3013024191
- Address
- 9 Ha'Ta'asiya Street, Ra'anana Central, Israel, 4365007
- Owner or operator
- Urogen Pharma Ltd. (10055966)
- Roles
- Specification developer
- First device listed
- October 24, 2017
- Registered through
- 2027
- Brand names listed
- Chilling Block Urogen, Intravesical Administation Kit, UGenLok, Universal Chilling Block, Ureteral Catheter Administration Kit, UroGen Ureteral Catheter, UroGen Urinary Catheter, Uroject12 Syringe Lever
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Adaptor, Ureteral Catheter | EYI | 1 | Specification developer | accessdata.fda.gov |
| Catheter Care Tray | OHR | 2 | Specification developer | accessdata.fda.gov |
| Catheter, Coude | EZC | 2 | Specification developer | accessdata.fda.gov |
| Catheter, Urological | KOD | 2 | Specification developer | accessdata.fda.gov |
| Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | LXG | 1 | Specification developer | accessdata.fda.gov |
| Piston Syringe Lever | QBL | 2 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 19, 2021 | K211032 | Urinary Catheter 12 Fr, Urinary Catheter 16 Fr | KOD | Substantially Equivalent | Urogen Pharma, Ltd. | accessdata.fda.gov |
| October 30, 2018 | K180354 | UroGen Ureteral Catheter | KOD | Substantially Equivalent | Urogen Pharma, Ltd. | accessdata.fda.gov |
| October 17, 2018 | K180345 | Uroject12 Syringe Lever | QBL | Substantially Equivalent | Urogen Pharma, Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Catheter Care Tray
- All makers of Adaptor, Ureteral Catheter
- All makers of Catheter, Urological
- All makers of Catheter, Coude
- All makers of Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
Updated November 19, 2021. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.