Uromed Corp.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Uromed Corp.” (first 1997, latest 2001), plus 1 PMA decision, across 8 product codes in 4 review panels. Median 510(k) review time under this name: 88 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 |
|---|---|---|---|
| ETN | Stimulator, Nerve | 3 | 3 |
| FGM | Probe And Director, Gastro-Urology | 2 | 2 |
| FHA | Clamp, Penile | 1 | 1 |
| KNA | Instrument, Manual, Specialized Obstetric-Gynecologic | 1 | 1 |
| KXK | Source, Brachytherapy, Radionuclide | 1 | 1 |
| MNG | External Urethral Occluder, Urinary Incontinence-Control, Female | 1 | 1 |
| OCK | Transurethral Occlusion Insert, Urinary Incontinence-Control, Female | 1 | 0 |
| OCW | Endoscopic Tissue Approximation Device | 1 | 1 |
Review panels
Most recent Uromed Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K010213 | MODIFICATION TO CAVERMAP SURGICAL AID | ETN | 2001-04-20 | 87 |
| K010098 | MODIFICATION TO CAVERMAP SURGICAL AID | FGM | 2001-02-01 | 21 |
| K000507 | CAVERMAP SURGICAL AID | ETN | 2000-04-21 | 66 |
| K993436 | CAVERMAP SURGICAL AID | FGM | 2000-02-11 | 122 |
| K982226 | UROMED BRACHYTHERAPHY IODINE-125 SOURCES | KXK | 1999-05-13 | 323 |
| K980717 | UROMED SLING KIT | KNA | 1998-05-22 | 87 |
| K974600 | UROMED PATCH | MNG | 1998-03-31 | 112 |
| K974137 | UROMED NEEDLE GRASPER | OCW | 1998-01-30 | 88 |
| K970971 | URO MED NERVE STIMULATOR | ETN | 1997-10-27 | 224 |
| K971992 | UROMED ALTERNATIVE BLADDER CONTROL CONTINENCE DEVICE(ABCPN-0026) | FHA | 1997-08-01 | 64 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P960020 | PMA | RELIANCE URINARY CONTROL INSERT AND SIZING DEVICE | 1996-08-16 |
Recalls
openFDA lists no recalls under a recalling firm named Uromed Corp..
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 Uromed Corp.?
FDA lists 10 510(k) clearances under the applicant name “Uromed Corp.” (first 1997, latest 2001), plus 1 PMA decision, across 8 product codes in 4 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 Uromed Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Uromed Corp. is 88 days.
Which FDA product codes appear under Uromed Corp.?
The most frequent FDA product codes under this applicant name are ETN (Stimulator, Nerve, 3); FGM (Probe And Director, Gastro-Urology, 2); FHA (Clamp, Penile, 1).
Next steps
- See all 10 Uromed Corp. clearances with predicates and recalls
- Run predicate analysis for product code ETN, Uromed Corp.'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.