DERMABOND PRINEO Skin Closure System— 510(k) K163645

Name: FDA 510(k) clearance K163645
Creator: U.S. Food and Drug Administration
Published: 2017-04-21

Substantially Equivalent

Ethicon, LLC

FDA 510(k) clearance K163645 for DERMABOND PRINEO Skin Closure System, Substantially Equivalent on 2017-04-21. Applicant: Ethicon, LLC. Device class: 2.

Clearance details

Applicant: Ethicon, LLC
Product code: Code OMD
Device class: Class 2
Regulation: 21 CFR 878.4011
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 ↗

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K233460 — CM00622 LINC Skin Closure System (CM00622 LINC)2024-07-15
K211878 — LiquiBand XL2022-05-23
K213512 — DERMABOND PRINEO Skin Closure System2021-12-07
K191461 — Exofin Fusion Skin Closure System2020-06-05
K171442 — Exofin Fusion Skin Closure System2017-09-25

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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.