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FDA 510(k)

CM00622 LINC Skin Closure System (CM00622 LINC)

K-Number: K233460 · 2024-07-15

ApplicantConnexicon Medical , Ltd.
Decision Date2024-07-15
Product CodeOMD
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CM00622 LINC Skin Closure System (CM00622 LINC) is the device name listed in this FDA 510(k) record. The listed applicant is Connexicon Medical , Ltd.. It received FDA 510(k) clearance on 2024-07-15 under 510(k) number K233460. 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 CM00622 LINC Skin Closure System (CM00622 LINC)?

CM00622 LINC Skin Closure System (CM00622 LINC) is a medical device that received FDA 510(k) clearance on 2024-07-15. The listed applicant is Connexicon Medical , Ltd.. The 510(k) number is K233460.

When did CM00622 LINC Skin Closure System (CM00622 LINC) receive FDA 510(k) clearance?

CM00622 LINC Skin Closure System (CM00622 LINC) received FDA 510(k) clearance on 2024-07-15, under 510(k) number K233460.

Who is the listed applicant for CM00622 LINC Skin Closure System (CM00622 LINC)?

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

What is the FDA product code for CM00622 LINC Skin Closure System (CM00622 LINC)?

The FDA product code for CM00622 LINC Skin Closure System (CM00622 LINC) is OMD.

Other records listing Connexicon Medical , Ltd. as applicant

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.

K233458CM005 Standard (CM005); CM004 Mini (CM004)

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.

K211878LiquiBand XLAdvanced Medical Solutions LimitedK213512DERMABOND PRINEO Skin Closure SystemETHICON, Inc.K191461Exofin 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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