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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 the device name listed in this FDA 510(k) record. The listed applicant is ETHICON, Inc.. It received FDA 510(k) clearance on 2021-12-07 under 510(k) 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. The listed applicant is ETHICON, Inc.. The 510(k) number is K213512.

When did DERMABOND PRINEO Skin Closure System receive FDA 510(k) clearance?

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

Who is the listed applicant for DERMABOND PRINEO Skin Closure System?

The FDA 510(k) record lists ETHICON, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

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Other records listing ETHICON, Inc. as applicant

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Related Devices (Code: OMD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K233460CM00622 LINC Skin Closure System (CM00622 LINC)Connexicon Medical , Ltd.K211878LiquiBand XLAdvanced Medical Solutions LimitedK191461Exofin Fusion Skin Closure SystemChemence Medical, Inc.K171442Exofin Fusion Skin Closure SystemChemence Medical, Inc.K163645DERMABOND PRINEO Skin Closure SystemEthicon, LLC

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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