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FDA 510(k)

AESCULAP HISTOACRYL FLEXIBLE TOPICAL SKIN ADHESIVE

K-Number: K121976 · 2013-05-17

ApplicantAesculap, Inc.
Decision Date2013-05-17
Product CodeMPN
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

AESCULAP HISTOACRYL FLEXIBLE TOPICAL SKIN ADHESIVE is the device name listed in this FDA 510(k) record. The listed applicant is Aesculap, Inc.. It received FDA 510(k) clearance on 2013-05-17 under 510(k) number K121976. 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 AESCULAP HISTOACRYL FLEXIBLE TOPICAL SKIN ADHESIVE?

AESCULAP HISTOACRYL FLEXIBLE TOPICAL SKIN ADHESIVE is a medical device that received FDA 510(k) clearance on 2013-05-17. The listed applicant is Aesculap, Inc.. The 510(k) number is K121976.

When did AESCULAP HISTOACRYL FLEXIBLE TOPICAL SKIN ADHESIVE receive FDA 510(k) clearance?

AESCULAP HISTOACRYL FLEXIBLE TOPICAL SKIN ADHESIVE received FDA 510(k) clearance on 2013-05-17, under 510(k) number K121976.

Who is the listed applicant for AESCULAP HISTOACRYL FLEXIBLE TOPICAL SKIN ADHESIVE?

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

What is the FDA product code for AESCULAP HISTOACRYL FLEXIBLE TOPICAL SKIN ADHESIVE?

The FDA product code for AESCULAP HISTOACRYL FLEXIBLE TOPICAL SKIN ADHESIVE is MPN.

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Other records listing Aesculap, Inc. as applicant

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K242762Aesculap Aicon® Series Container SystemK242003XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter SetK223596SQ.line KERRISONK214041Aesculap AICON ContainerK211572Aesculap Slim Clip ApplierK203739ELAN 4 Electro Motor System

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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

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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