Urogen Pharma, Ltd.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Urogen Pharma, Ltd.” (first 2018, latest 2021), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 231 days. Since 2017 the median was 231 days, against 241 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2018 | 2 | 258 |
| 2019 | 1 | 231 |
| 2020 | 1 | 27 |
| 2021 | 1 | 226 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Urogen Pharma, Ltd. took a median 231 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 241 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| QBL | Piston Syringe Lever | 3 | 3 |
| KOD | Catheter, Urological | 2 | 2 |
Review panels
Most recent Urogen Pharma, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K211032 | Urinary Catheter 12 Fr, Urinary Catheter 16 Fr | KOD | 2021-11-19 | 226 |
| K203321 | Cystoject Syringe Lever | QBL | 2020-12-09 | 27 |
| K190987 | Uroject12 Syringe Lever | QBL | 2019-12-02 | 231 |
| K180354 | UroGen Ureteral Catheter | KOD | 2018-10-30 | 264 |
| K180345 | Uroject12 Syringe Lever | QBL | 2018-10-17 | 251 |
Recalls
openFDA lists no recalls under a recalling firm named Urogen Pharma, Ltd..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Urogen Pharma, Ltd. is the lead sponsor of 4 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT01997983: Efficacy and Safety of Intravesical Instillations of Botulinum Toxin in TC-3 Gel in IC Patients (Completed, started 2013-11)
- NCT01803295: Pre-TURBT TC-3 Gel Intravesical Instillation in NMIBC (Completed, started 2013-06)
- NCT02891460: Pilot Study to Evaluate the Clinical Response to Mitomycin-C in Hydrogel (TC-3) Administered Intravesically in NMIBC Patients (Completed, started 2013-01)
- NCT01648010: Safety and Tolerability Study Which Evaluate Intravesical Instillation With Mitomycin C Mixed With TC-3 Drug Retaining Hydrogel Device In Patients With Muscle Invasive Bladder Cancer (Completed, started 2011-11)
SEC filings
UroGen Pharma Ltd. (URGN): EDGAR filings, CIK 1668243. An SEC registrant with the same name, matched by name only.
Frequently asked questions
How many FDA 510(k) clearances are listed under Urogen Pharma, Ltd.?
FDA lists 5 510(k) clearances under the applicant name “Urogen Pharma, Ltd.” (first 2018, latest 2021), across 2 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Urogen Pharma, Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Urogen Pharma, Ltd. is 231 days. Since 2017: 231 days, versus 241 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Urogen Pharma, Ltd.?
The most frequent FDA product codes under this applicant name are QBL (Piston Syringe Lever, 3); KOD (Catheter, Urological, 2).
Next steps
- See all 5 Urogen Pharma, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code QBL, Urogen Pharma, Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.