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FDA 510(k)

GLUSITE, MODEL GLU002

K-Number: K013446 · 2001-12-20

ApplicantGlustitch, Inc.
Decision Date2001-12-20
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

GLUSITE, MODEL GLU002 is the device name listed in this FDA 510(k) record. The listed applicant is Glustitch, Inc.. It received FDA 510(k) clearance on 2001-12-20 under 510(k) number K013446. The device is classified under product code EMA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GLUSITE, MODEL GLU002?

GLUSITE, MODEL GLU002 is a medical device that received FDA 510(k) clearance on 2001-12-20. The listed applicant is Glustitch, Inc.. The 510(k) number is K013446.

When did GLUSITE, MODEL GLU002 receive FDA 510(k) clearance?

GLUSITE, MODEL GLU002 received FDA 510(k) clearance on 2001-12-20, under 510(k) number K013446.

Who is the listed applicant for GLUSITE, MODEL GLU002?

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 GLUSITE, MODEL GLU002?

The FDA product code for GLUSITE, MODEL GLU002 is EMA.

Related Clinical Trials

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Other records listing Glustitch, Inc. 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.

K150032GluStitch Twist Tissue AdhesiveK083752GLUSEAL 90, MODEL GLU9010K071484PERIACRYL 90,80,70,60, MODEL9010, 8020, 7030, 6040K030574GLUSEAL 5ML DISPENSER, 1 ML DISPENSER, .2 ML DISPENSER

Related Devices (Code: EMA)

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.

K262983EsTemp ImplantSpident Co., Ltd.K254201Any-CemMediclus Co., Ltd.K261937PacTemp Automix NEThe Belport Company Inc., DBA Gingi-PakK261166DIA-CEMDiaDent Group InternationalK254109G-CEM UNIVERSALGC America, Inc.K253337REGEN Bioactive CementInter-Med, 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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