Applied Urology, Inc.: FDA clearances and approvals
Applied Urology, Inc. has 13 FDA 510(k) clearances (first 1990, latest 1993), across 11 product codes in 3 review panels. Median 510(k) review time: 79 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FAD | Stent, Ureteral | 2 | 2 |
| FAS | Electrode, Electrosurgical, Active, Urological | 2 | 2 |
| EYB | Catheter, Ureteral, Gastro-Urology | 1 | 1 |
| FFY | Adaptor, Bulbs, Miscellaneous, For Endoscope | 1 | 1 |
| FGB | Ureteroscope And Accessories, Flexible/Rigid | 1 | 1 |
| FGF | Catheter, Ureteral Disposable (X-Ray) | 1 | 1 |
| GCJ | Laparoscope, General & Plastic Surgery | 1 | 1 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 | 1 |
| HET | Laparoscope, Gynecologic (And Accessories) | 1 | 1 |
| KOD | Catheter, Urological | 1 | 1 |
Plus 1 more product codes.
Review panels
Most recent Applied Urology, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K921838 | ACUCISE URETERAL CUTTING CATHETER | EYB | 1993-02-26 | 315 |
| K925282 | UROLOGICAL CATHETER AND ACCESSORIES | FAD | 1993-01-13 | 85 |
| K920695 | URETERAL STENT | FAD | 1992-09-23 | 222 |
| K915219 | URETHRAL ELECTRODE SHEATH | FAS | 1992-07-23 | 246 |
| K912093 | DISPOSABLE ASPIRATION IRRIGATION SYSTEM | HET | 1992-04-24 | 346 |
| K920030 | SURESEAL ENDOSCOPIC VALVE | ODC | 1992-03-18 | 75 |
| K912656 | ENDOSCOPIC ELECTRODE | GEI | 1991-09-16 | 91 |
| K912903 | PERCUTANEOUS RETRACTOR KIT | GCJ | 1991-08-16 | 45 |
| K905731 | FLEXIBLE ENDOSCOPIC ELECTRODE | FAS | 1991-01-31 | 38 |
| K903994 | URETEROPYELOGRAM CATH FOR RETROGRADE DYE INJECTION | FGF | 1990-10-19 | 51 |
3 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Applied Urology, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Applied Urology, Inc. have?
Applied Urology, Inc. has 13 FDA 510(k) clearances (first 1990, latest 1993), across 11 product codes in 3 review panels.
How long does FDA take to clear Applied Urology, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Applied Urology, Inc.'s cleared 510(k)s is 79 days.
What devices does Applied Urology, Inc. make?
Its most frequent FDA product codes are FAD (Stent, Ureteral, 2); FAS (Electrode, Electrosurgical, Active, Urological, 2); EYB (Catheter, Ureteral, Gastro-Urology, 1).
Has Applied Urology, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Applied Urology, Inc. Related entities may recall under other names.
Next steps
- See all 13 Applied Urology, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FAD, Applied Urology, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.