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FDA 510(k)

DERMABOND PRINEO Skin Closure System

K-Number: K213512 · 2021-12-07

ApplicantETHICON, Inc.
Decision Date2021-12-07
Product CodeOMD
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DERMABOND PRINEO Skin Closure System is a medical device manufactured by ETHICON, Inc.. It received FDA 510(k) clearance on 2021-12-07 under approval number K213512. The device is classified under product code OMD. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DERMABOND PRINEO Skin Closure System?

DERMABOND PRINEO Skin Closure System is a medical device that received FDA 510(k) clearance on 2021-12-07. It is manufactured by ETHICON, Inc.. The 510(k) number is K213512.

When was DERMABOND PRINEO Skin Closure System approved by the FDA?

DERMABOND PRINEO Skin Closure System received FDA 510(k) clearance on 2021-12-07, under approval number K213512.

What company makes DERMABOND PRINEO Skin Closure System?

DERMABOND PRINEO Skin Closure System is manufactured by ETHICON, Inc..

What is the FDA product code for DERMABOND PRINEO Skin Closure System?

The FDA product code for DERMABOND PRINEO Skin Closure System is OMD.

Related Clinical Trials

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Related Devices (Code: OMD)

K171442Exofin Fusion Skin Closure SystemChemence Medical, Inc. K163645DERMABOND PRINEO Skin Closure SystemEthicon, LLC K191461Exofin Fusion Skin Closure SystemChemence Medical, Inc. K211878LiquiBand XLAdvanced Medical Solutions Limited K233460CM00622 LINC Skin Closure System (CM00622 LINC)Connexicon Medical , Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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