Applied Urology, Inc.: FDA filings under this applicant name
FDA lists 13 510(k) clearances under the applicant name “Applied Urology, Inc.” (first 1990, latest 1993), across 11 product codes in 3 review panels. Median 510(k) review time under this name: 79 days. 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 |
|---|---|---|
| 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 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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Applied Medical Resources (115 510(k)s)
- Applied Medical Technology, Inc. (25 510(k)s)
- Applied Medical Technologies (24 510(k)s)
- Applied Medical Research (22 510(k)s)
- Applied Vascular Devices, Inc. (21 510(k)s)
- Applied Osteo Systems, Inc. (15 510(k)s)
- Applied Medical (14 510(k)s)
- Applied Medical Devices, Inc. (11 510(k)s)
- Applied Laboratories, Inc. (9 510(k)s)
- Applied Spectral Imaging , Ltd. (8 510(k)s)
- Applied Biomaterial Technologies (7 510(k)s)
- Applied Imaging Corp. (7 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Applied Urology, Inc.?
FDA lists 13 510(k) clearances under the applicant name “Applied Urology, Inc.” (first 1990, latest 1993), across 11 product codes in 3 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 Applied Urology, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Applied Urology, Inc. is 79 days.
Which FDA product codes appear under Applied Urology, Inc.?
The most frequent FDA product codes under this applicant name are FAD (Stent, Ureteral, 2); FAS (Electrode, Electrosurgical, Active, Urological, 2); EYB (Catheter, Ureteral, Gastro-Urology, 1).
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. 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.