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FDA 510(k)

MICROPERFORATION INSTRUMENT

K-Number: K001507 · 2000-06-14

ApplicantSmith & Nephew, Inc.
Decision Date2000-06-14
Product CodeLXH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MICROPERFORATION INSTRUMENT is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew, Inc.. It received FDA 510(k) clearance on 2000-06-14 under 510(k) number K001507. The device is classified under product code LXH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MICROPERFORATION INSTRUMENT?

MICROPERFORATION INSTRUMENT is a medical device that received FDA 510(k) clearance on 2000-06-14. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K001507.

When did MICROPERFORATION INSTRUMENT receive FDA 510(k) clearance?

MICROPERFORATION INSTRUMENT received FDA 510(k) clearance on 2000-06-14, under 510(k) number K001507.

Who is the listed applicant for MICROPERFORATION INSTRUMENT?

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

What is the FDA product code for MICROPERFORATION INSTRUMENT?

The FDA product code for MICROPERFORATION INSTRUMENT is LXH.

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Other records listing Smith & Nephew, Inc. as applicant

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Related Devices (Code: LXH)

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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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