Laboratoires Urgo: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Laboratoires Urgo” (first 2006, latest 2015), across 1 product code in 1 review panel. Median 510(k) review time under this name: 134 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 | 1 | 154 |
| 2014 | 0 | — |
| 2015 | 1 | 291 |
| 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 |
|---|---|---|---|
| FRO | Dressing, Wound, Drug | 6 | 6 |
Review panels
Most recent Laboratoires Urgo 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K143017 | Urgoclean Ag, Antibacterial Absorbent Wound Dressing with Silver | FRO | 2015-08-07 | 291 |
| K123219 | URGOCLEAN ABSORBENT WOUND DRESSING | FRO | 2013-03-18 | 154 |
| K100430 | URGOTUL AG, ANTIMICROBIAL WOUND DRESSING WITH SILVER | FRO | 2010-06-11 | 115 |
| K100429 | URGOCELL AG, ANTIMICROBIAL WOUND DRESSING WITH SILVER | FRO | 2010-06-11 | 115 |
| K062559 | URGOCELL AG ANTIMICROBIAL WOUND DRESSING WITH SILVER | FRO | 2007-01-29 | 152 |
| K061220 | URGOTUL AG | FRO | 2006-07-27 | 87 |
Recalls
openFDA lists no recalls under a recalling firm named Laboratoires Urgo.
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 Laboratoires Urgo is the lead sponsor of 4 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT06899919: Efficacy and Safety of Light Compression System in the Local Treatment of Mixed Leg Ulcers (PROMETHEE Clinical Investigation) (Recruiting, started 2025-03-29)
- NCT05158764: Efficacy and Safety of URGOBD001 Compression System (Completed, started 2021-12-03)
- NCT03126396: Assessment of Efficacy & Tolerance of Urgo 310 3166 Dressing in Local Venous or Mixed Leg Ulcers (Completed, started 2017-05-11)
- NCT01449422: Clinical Trial to Evaluate the Efficacy, Tolerance and Acceptability of URGO Dressing vs a Hydrofibre in the Local Management of Venous or Predominantly Venous Mixed Leg Ulcers. (Completed, started 2011-05)
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.
- Laboratoires Urgo S.A. (2 510(k)s)
- Laboratoires Carilene S.A.S. (1 510(k)s)
- Laboratoires Luneau (1 510(k)s)
- Laboratoires Perouse (1 510(k)s)
- Laboratoires Prodimed (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Laboratoires Urgo?
FDA lists 6 510(k) clearances under the applicant name “Laboratoires Urgo” (first 2006, latest 2015), across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Laboratoires Urgo?
The median time from FDA receipt to decision across 510(k)s cleared under the name Laboratoires Urgo is 134 days.
Which FDA product codes appear under Laboratoires Urgo?
The most frequent FDA product codes under this applicant name are FRO (Dressing, Wound, Drug, 6).
Next steps
- See all 6 Laboratoires Urgo clearances with predicates and recalls
- Run predicate analysis for product code FRO, Laboratoires Urgo'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.