The Urology Group: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “The Urology Group” (first 1980, latest 1984), across 6 product codes in 2 review panels. Median 510(k) review time under this name: 64 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 |
|---|---|---|---|
| FZX | Guide, Surgical, Instrument | 1 | 1 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 | 1 |
| KNX | Collector, Urine, (And Accessories) For Indwelling Catheter | 1 | 1 |
| KQT | Evacuator, Gastro-Urology | 1 | 1 |
| NAD | Dressing, Wound, Occlusive | 1 | 1 |
| OCV | Endoscope Holder | 1 | 1 |
Review panels
Most recent The Urology Group 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K831703 | COVERUPS | NAD | 1984-01-03 | 223 |
| K831489 | SURGICAL TUBE HOLDER | GEI | 1983-12-12 | 216 |
| K810739 | SUCTION WOUND DRAINAGE DEVICE | KQT | 1981-06-26 | 99 |
| K810788 | SURGICAL TUBE HOLDER | FZX | 1981-04-17 | 25 |
| K810787 | UROLOGIC TUBE HOLDER | OCV | 1981-03-31 | 8 |
| K801629 | COVER-ALL MALE INCONTINENCE DEVICE | KNX | 1980-08-12 | 28 |
Recalls
openFDA lists no recalls under a recalling firm named The Urology Group.
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under The Urology Group?
FDA lists 6 510(k) clearances under the applicant name “The Urology Group” (first 1980, latest 1984), across 6 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 The Urology Group?
The median time from FDA receipt to decision across 510(k)s cleared under the name The Urology Group is 64 days.
Which FDA product codes appear under The Urology Group?
The most frequent FDA product codes under this applicant name are FZX (Guide, Surgical, Instrument, 1); GEI (Electrosurgical, Cutting & Coagulation & Accessories, 1); KNX (Collector, Urine, (And Accessories) For Indwelling Catheter, 1).
Next steps
- See all 6 The Urology Group clearances with predicates and recalls
- Run predicate analysis for product code FZX, The Urology Group'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.