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FDA 510(k)

GELZONE

K-Number: K013732 · 2002-02-07

ApplicantImplantech Associates, Inc.
Decision Date2002-02-07
Product CodeMDA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

GELZONE is the device name listed in this FDA 510(k) record. The listed applicant is Implantech Associates, Inc.. It received FDA 510(k) clearance on 2002-02-07 under 510(k) number K013732. The device is classified under product code MDA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GELZONE?

GELZONE is a medical device that received FDA 510(k) clearance on 2002-02-07. The listed applicant is Implantech Associates, Inc.. The 510(k) number is K013732.

When did GELZONE receive FDA 510(k) clearance?

GELZONE received FDA 510(k) clearance on 2002-02-07, under 510(k) number K013732.

Who is the listed applicant for GELZONE?

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

What is the FDA product code for GELZONE?

The FDA product code for GELZONE is MDA.

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Other records listing Implantech Associates, 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.

K200610Customized Contour ImplantK191130Customized Contour ImplantK172389ePTFE-Coated Auricular ImplantK071470IMPLANTECH EPTFE SHEETING, MODEL EPTFE-XXXK052505CALF IMPLANT, MODEL EC17-XK052504GLUTEAL IMPLANT, MODELS RND 5-X, TRD 6-X

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Related Devices (Code: MDA)

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.

K112131NEODYNE DRESSINGNeodyne Biosciences, Inc.K111733CORELEADER SCAR-DIMMERCoreleader Biotech Co., Ltd.K083718BEAU RX SCAR CARE GELBeau RX Solutions, LLCK053481KELO-COTE SPRAYAdvanced Bio-Technologies, Inc.K041704NEWGEL AND NEWGEL PLUS ENewmedical Technology, Inc.K040307HANSON SCAR ADEHanson 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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