COVACLEARAG COLLAGEN WITH SILVER ANTIMICROBIAL GEL SHEET DRESSING— 510(k) K052696

Substantially Equivalent

Covalon Technologies, Ltd.

FDA 510(k) clearance K052696 for COVACLEARAG COLLAGEN WITH SILVER ANTIMICROBIAL GEL SHEET DRESSING, Substantially Equivalent on 2006-02-03. Applicant: Covalon Technologies, Ltd..

Clearance details

Applicant: Covalon Technologies, Ltd.
Product code: Code FRO
Advisory panel: Unknown
Date received: 2005-09-28
Decision date: 2006-02-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waxhaw, NC, US

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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.