FDA 510(k)

CONTOUR TRANSTAR CURVED CUTTER STAPLER SET

K-Number: K053631 · 2006-01-30

Decision Date2006-01-30

Product CodeGDW

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

CONTOUR TRANSTAR CURVED CUTTER STAPLER SET is the device name listed in this FDA 510(k) record. The listed applicant is Ethicon Endo-Surgery, Inc.. It received FDA 510(k) clearance on 2006-01-30 under 510(k) number K053631. The device is classified under product code GDW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CONTOUR TRANSTAR CURVED CUTTER STAPLER SET?

CONTOUR TRANSTAR CURVED CUTTER STAPLER SET is a medical device that received FDA 510(k) clearance on 2006-01-30. The listed applicant is Ethicon Endo-Surgery, Inc.. The 510(k) number is K053631.

When did CONTOUR TRANSTAR CURVED CUTTER STAPLER SET receive FDA 510(k) clearance?

CONTOUR TRANSTAR CURVED CUTTER STAPLER SET received FDA 510(k) clearance on 2006-01-30, under 510(k) number K053631.

Who is the listed applicant for CONTOUR TRANSTAR CURVED CUTTER STAPLER SET?

The FDA 510(k) record lists Ethicon Endo-Surgery, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CONTOUR TRANSTAR CURVED CUTTER STAPLER SET?

The FDA product code for CONTOUR TRANSTAR CURVED CUTTER STAPLER SET is GDW.

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Other records listing Ethicon Endo-Surgery, Inc. as applicant

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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.