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FDA 510(k)

ACTABOND Topical Skin Adhesive

K-Number: K161050 · 2016-10-04

ApplicantBergen Medical Products, Inc.
Decision Date2016-10-04
Product CodeMPN
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ACTABOND Topical Skin Adhesive is the device name listed in this FDA 510(k) record. The listed applicant is Bergen Medical Products, Inc.. It received FDA 510(k) clearance on 2016-10-04 under 510(k) number K161050. The device is classified under product code MPN. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACTABOND Topical Skin Adhesive?

ACTABOND Topical Skin Adhesive is a medical device that received FDA 510(k) clearance on 2016-10-04. The listed applicant is Bergen Medical Products, Inc.. The 510(k) number is K161050.

When did ACTABOND Topical Skin Adhesive receive FDA 510(k) clearance?

ACTABOND Topical Skin Adhesive received FDA 510(k) clearance on 2016-10-04, under 510(k) number K161050.

Who is the listed applicant for ACTABOND Topical Skin Adhesive?

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

What is the FDA product code for ACTABOND Topical Skin Adhesive?

The FDA product code for ACTABOND Topical Skin Adhesive is MPN.

Related Clinical Trials

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.

NCT062170813M™ Topical Tissue Adhesive Versus Commercially Available Tissue Adhesive for the Closure of Lacerations and IncisionsTERMINATED

Related Devices (Code: MPN)

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.

K243990BondEase 2 Topical Skin AdhesiveOptmed, Inc.K250950CUTIVA™ Topical Skin Adhesive (RM1700); CUTIVA™ PLUS Skin Closure System (RM1739)Okapi Medical, LLC Dba Resivant MedicalK234114CUTIVA(TM) Topical Skin Adhesive (RM-1700); CUTIVA(TM) PLUS Skin Closure System (RM-1739)Okapi Medical, LLC Dba Resivant MedicalK233458CM005 Standard (CM005); CM004 Mini (CM004)Connexicon Medical , Ltd.K230981Meriglu Topical Skin AdhesiveM/s. Meril Endo Surgery Private Limited.K212246Exofin Precision PenChemence Medical, Inc.

Official Source

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

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