FDA 510(k)

VALUTRUS REUSABLE CIRCULAR STAPLER AND DISPOSABLE RELOADS

K-Number: K111195 · 2011-08-03

Decision Date2011-08-03

Product CodeGDW

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

VALUTRUS REUSABLE CIRCULAR STAPLER AND DISPOSABLE RELOADS 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 2011-08-03 under 510(k) number K111195. 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 VALUTRUS REUSABLE CIRCULAR STAPLER AND DISPOSABLE RELOADS?

VALUTRUS REUSABLE CIRCULAR STAPLER AND DISPOSABLE RELOADS is a medical device that received FDA 510(k) clearance on 2011-08-03. The listed applicant is Ethicon Endo-Surgery, Inc.. The 510(k) number is K111195.

When did VALUTRUS REUSABLE CIRCULAR STAPLER AND DISPOSABLE RELOADS receive FDA 510(k) clearance?

VALUTRUS REUSABLE CIRCULAR STAPLER AND DISPOSABLE RELOADS received FDA 510(k) clearance on 2011-08-03, under 510(k) number K111195.

Who is the listed applicant for VALUTRUS REUSABLE CIRCULAR STAPLER AND DISPOSABLE RELOADS?

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 VALUTRUS REUSABLE CIRCULAR STAPLER AND DISPOSABLE RELOADS?

The FDA product code for VALUTRUS REUSABLE CIRCULAR STAPLER AND DISPOSABLE RELOADS is GDW.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.