DERMABOND PRINEO Skin Closure System— 510(k) K163645

Substantially Equivalent

Ethicon, LLC

FDA 510(k) clearance K163645 for DERMABOND PRINEO Skin Closure System, Substantially Equivalent on 2017-04-21. Applicant: Ethicon, LLC.

Clearance details

Applicant: Ethicon, LLC
Product code: Code OMD
Advisory panel: General, Plastic Surgery
Date received: 2016-12-23
Decision date: 2017-04-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Somerville, NJ, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code OMD

product code OMD

Injury: 1,134
Total: 1,134

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.