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FDA 510(k)

GluStitch Twist Tissue Adhesive

K-Number: K150032 · 2016-01-14

ApplicantGlustitch, Inc.
Decision Date2016-01-14
Product CodeMPN
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

GluStitch Twist Tissue Adhesive is the device name listed in this FDA 510(k) record. The listed applicant is Glustitch, Inc.. It received FDA 510(k) clearance on 2016-01-14 under 510(k) number K150032. 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 GluStitch Twist Tissue Adhesive?

GluStitch Twist Tissue Adhesive is a medical device that received FDA 510(k) clearance on 2016-01-14. The listed applicant is Glustitch, Inc.. The 510(k) number is K150032.

When did GluStitch Twist Tissue Adhesive receive FDA 510(k) clearance?

GluStitch Twist Tissue Adhesive received FDA 510(k) clearance on 2016-01-14, under 510(k) number K150032.

Who is the listed applicant for GluStitch Twist Tissue Adhesive?

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

What is the FDA product code for GluStitch Twist Tissue Adhesive?

The FDA product code for GluStitch Twist Tissue Adhesive is MPN.

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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