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FDA 510(k)

INTRASITE GEL

K-Number: K926508 · 1993-07-13

ApplicantSmith & Nephew United, Inc.
Decision Date1993-07-13
Product CodeNAE
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

INTRASITE GEL is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew United, Inc.. It received FDA 510(k) clearance on 1993-07-13 under 510(k) number K926508. 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 INTRASITE GEL?

INTRASITE GEL is a medical device that received FDA 510(k) clearance on 1993-07-13. The listed applicant is Smith & Nephew United, Inc.. The 510(k) number is K926508.

When did INTRASITE GEL receive FDA 510(k) clearance?

INTRASITE GEL received FDA 510(k) clearance on 1993-07-13, under 510(k) number K926508.

Who is the listed applicant for INTRASITE GEL?

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

What is the FDA product code for INTRASITE GEL?

The FDA product code for INTRASITE GEL is NAE.

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Other records listing Smith & Nephew United, 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.

K963096ALLEVYN HYDRO POLY DRESSING ND ALL TRAC DRESSINGK961775PROFORE FOUR-LAYER BANDAGE SYSTEM KITK945330ALLEVYN ADHESIVEK943619CAVI-CARE CONFORMING FOAM DRESSINGK942748INTRASITEK935705ALLEVYN ISLAND WOUND DRESSING

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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.

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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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