URGOCELL AG, ANTIMICROBIAL WOUND DRESSING WITH SILVER— 510(k) K100429

Substantially Equivalent

Laboratoires Urgo

FDA 510(k) clearance K100429 for URGOCELL AG, ANTIMICROBIAL WOUND DRESSING WITH SILVER, Substantially Equivalent on 2010-06-11. Applicant: Laboratoires Urgo.

Clearance details

Applicant: Laboratoires Urgo
Product code: Code FRO
Advisory panel: Unknown
Date received: 2010-02-16
Decision date: 2010-06-11
Decision: Substantially Equivalent
Clearance type: Special
Location: 21300 Chenove, FR

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Adverse events under product code FRO

product code FRO

Death: 30
Injury: 653
Malfunction: 479
Other: 11
Total: 1,173

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.