ReliaTect Post-Op Dressing with CHG (8cm x 15cm), ReliaTect Post-Op Dressing with CHG (10cm x 25cm)— 510(k) K163529

Substantially Equivalent

Avery Dennison Corporation

FDA 510(k) clearance K163529 for ReliaTect Post-Op Dressing with CHG (8cm x 15cm), ReliaTect Post-Op Dressing with CHG (10cm x 25cm), Substantially Equivalent on 2017-03-29. Applicant: Avery Dennison Corporation.

Clearance details

Applicant: Avery Dennison Corporation
Product code: Code FRO
Advisory panel: Unknown
Date received: 2016-12-16
Decision date: 2017-03-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mentor, OH, 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.