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FDA 510(k)

GILTECH PLUS HYDROGEL SKIN DRESSING

K-Number: K992094 · 1999-09-17

ApplicantGiltech Plus, Inc.
Decision Date1999-09-17
Product CodeNAE
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

GILTECH PLUS HYDROGEL SKIN DRESSING is the device name listed in this FDA 510(k) record. The listed applicant is Giltech Plus, Inc.. It received FDA 510(k) clearance on 1999-09-17 under 510(k) number K992094. The device is classified under product code NAE. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GILTECH PLUS HYDROGEL SKIN DRESSING?

GILTECH PLUS HYDROGEL SKIN DRESSING is a medical device that received FDA 510(k) clearance on 1999-09-17. The listed applicant is Giltech Plus, Inc.. The 510(k) number is K992094.

When did GILTECH PLUS HYDROGEL SKIN DRESSING receive FDA 510(k) clearance?

GILTECH PLUS HYDROGEL SKIN DRESSING received FDA 510(k) clearance on 1999-09-17, under 510(k) number K992094.

Who is the listed applicant for GILTECH PLUS HYDROGEL SKIN DRESSING?

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

What is the FDA product code for GILTECH PLUS HYDROGEL SKIN DRESSING?

The FDA product code for GILTECH PLUS HYDROGEL SKIN DRESSING is NAE.

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.

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Other records listing Giltech Plus, 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.

K992005GILTECH PLUS TRANSPARENT DRESSINGK983624GILTECH PLUS CONNECTING TUBE SET

Related Devices (Code: NAE)

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.

K083721MODIFICATION TO ZENIEVARiver'S Edge Pharmaceuticals, LLCK082865MODIFICATION TO ZENIEVAGorbec Pharmaceutical Services, Inc.K073246ZENIEVAGorbec Pharmaceutical Services, Inc.K991061DERMAPHYLYX CALCIUM ALGINATE WOUND DRESSINGDermaphylyx, Inc.K972646AD-HEAL HYDROGEL DRESSING, VARIOUS SIZESLudlow Technical ProductsK971597COMFEEL PURILON GEL,15G(3900)/COMFEEL PURILON GEL,25G(3903)Coloplast Corp.

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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