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FDA 510(k)

INTRASITE

K-Number: K942748 · 1994-06-29

ApplicantSmith & Nephew United, Inc.
Decision Date1994-06-29
Product CodeNAE
Advisory CommitteeSU
DecisionSubstantially Equivalent for Some Indications

Device Summary

INTRASITE 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 1994-06-29 under 510(k) number K942748. The device is classified under product code NAE. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the INTRASITE?

INTRASITE is a medical device that received FDA 510(k) clearance on 1994-06-29. The listed applicant is Smith & Nephew United, Inc.. The 510(k) number is K942748.

When did INTRASITE receive FDA 510(k) clearance?

INTRASITE received FDA 510(k) clearance on 1994-06-29, under 510(k) number K942748.

Who is the listed applicant for INTRASITE?

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?

The FDA product code for INTRASITE is NAE.

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Other records listing Smith & Nephew United, Inc. as applicant

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Related Devices (Code: NAE)

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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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