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FDA 510(k)

INTRASITE GEL (LABELING REVISION)

K-Number: K904411 · 1990-11-26

ApplicantSmith & Nephew United, Inc.
Decision Date1990-11-26
Product CodeKMF
Advisory CommitteeHO
DecisionSubstantially Equivalent for Some Indications

Device Summary

INTRASITE GEL (LABELING REVISION) 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 1990-11-26 under 510(k) number K904411. The device is classified under product code KMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the INTRASITE GEL (LABELING REVISION)?

INTRASITE GEL (LABELING REVISION) is a medical device that received FDA 510(k) clearance on 1990-11-26. The listed applicant is Smith & Nephew United, Inc.. The 510(k) number is K904411.

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

INTRASITE GEL (LABELING REVISION) received FDA 510(k) clearance on 1990-11-26, under 510(k) number K904411.

Who is the listed applicant for INTRASITE GEL (LABELING REVISION)?

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 (LABELING REVISION)?

The FDA product code for INTRASITE GEL (LABELING REVISION) is KMF.

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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.

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Related Devices (Code: KMF)

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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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