COPA AMD ANTIMICROBIAL WOUND DRESSING— 510(k) K071371

Substantially Equivalent

Tyco Healthcare Group LP

FDA 510(k) clearance K071371 for COPA AMD ANTIMICROBIAL WOUND DRESSING, Substantially Equivalent on 2007-11-19. Applicant: Tyco Healthcare Group LP.

Clearance details

Applicant: Tyco Healthcare Group LP
Product code: Code FRO
Advisory panel: Unknown
Date received: 2007-05-16
Decision date: 2007-11-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mansfield, MA, US

Download summary PDF View on FDA.gov ↗

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.