KENDALL ANTIMICROBIAL DRAIN DRESSING FOR OTC USE, MODEL 6662— 510(k) K070685

Substantially Equivalent

Tyco Healthcare

FDA 510(k) clearance K070685 for KENDALL ANTIMICROBIAL DRAIN DRESSING FOR OTC USE, MODEL 6662, Substantially Equivalent on 2007-09-14. Applicant: Tyco Healthcare.

Clearance details

Applicant: Tyco Healthcare
Product code: Code FRO
Advisory panel: Unknown
Date received: 2007-03-12
Decision date: 2007-09-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mansfield, MA, 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.