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FDA 510(k)

ENDOBUTTON CONTINUOUS LOOP

K-Number: K980155 · 1998-04-01

ApplicantSmith & Nephew, Inc.
Decision Date1998-04-01
Product CodeGAT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ENDOBUTTON CONTINUOUS LOOP 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 1998-04-01 under 510(k) number K980155. 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 ENDOBUTTON CONTINUOUS LOOP?

ENDOBUTTON CONTINUOUS LOOP is a medical device that received FDA 510(k) clearance on 1998-04-01. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K980155.

When did ENDOBUTTON CONTINUOUS LOOP receive FDA 510(k) clearance?

ENDOBUTTON CONTINUOUS LOOP received FDA 510(k) clearance on 1998-04-01, under 510(k) number K980155.

Who is the listed applicant for ENDOBUTTON CONTINUOUS LOOP?

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 ENDOBUTTON CONTINUOUS LOOP?

The FDA product code for ENDOBUTTON CONTINUOUS LOOP is GAT.

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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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