FDA applicant
Urogen Pharma, Ltd.
FDA records 5 decisions for Urogen Pharma, Ltd. (Ra’Anana, IL) from 2018 to 2021: 5 510(k) clearances. Most are in product codes QBL (Piston Syringe Lever) and KOD (Catheter, Urological). Its devices cite 5 predicates, 3 of them its own earlier devices. No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Urogen Pharma, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2021
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2018.
Planning a device like Urogen Pharma, Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report