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FDA 510(k)

PRE-THREADED ENDOBUTTON

K-Number: K984550 · 1999-03-01

ApplicantSmith & Nephew, Inc.
Decision Date1999-03-01
Product CodeGAT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PRE-THREADED ENDOBUTTON 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 1999-03-01 under 510(k) number K984550. The device is classified under product code GAT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRE-THREADED ENDOBUTTON?

PRE-THREADED ENDOBUTTON is a medical device that received FDA 510(k) clearance on 1999-03-01. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K984550.

When did PRE-THREADED ENDOBUTTON receive FDA 510(k) clearance?

PRE-THREADED ENDOBUTTON received FDA 510(k) clearance on 1999-03-01, under 510(k) number K984550.

Who is the listed applicant for PRE-THREADED ENDOBUTTON?

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 PRE-THREADED ENDOBUTTON?

The FDA product code for PRE-THREADED ENDOBUTTON is GAT.

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Other records listing Smith & Nephew, Inc. as applicant

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Related Devices (Code: GAT)

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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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