FDA 510(k)

easyEndoTM Linear Cutting Stapler and Loading Units for Single Use, easyEndoTM Universal Linear Cutting Stapler and Loading Units for Single Use

K-Number: K172960 · 2017-12-21

Decision Date2017-12-21

Product CodeGDW

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

easyEndoTM Linear Cutting Stapler and Loading Units for Single Use, easyEndoTM Universal Linear Cutting Stapler and Loading Units for Single Use is the device name listed in this FDA 510(k) record. The listed applicant is Ezisurg Medical Co., Ltd.. It received FDA 510(k) clearance on 2017-12-21 under 510(k) number K172960. 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 easyEndoTM Linear Cutting Stapler and Loading Units for Single Use, easyEndoTM Universal Linear Cutting Stapler and Loading Units for Single Use?

easyEndoTM Linear Cutting Stapler and Loading Units for Single Use, easyEndoTM Universal Linear Cutting Stapler and Loading Units for Single Use is a medical device that received FDA 510(k) clearance on 2017-12-21. The listed applicant is Ezisurg Medical Co., Ltd.. The 510(k) number is K172960.

When did easyEndoTM Linear Cutting Stapler and Loading Units for Single Use, easyEndoTM Universal Linear Cutting Stapler and Loading Units for Single Use receive FDA 510(k) clearance?

easyEndoTM Linear Cutting Stapler and Loading Units for Single Use, easyEndoTM Universal Linear Cutting Stapler and Loading Units for Single Use received FDA 510(k) clearance on 2017-12-21, under 510(k) number K172960.

Who is the listed applicant for easyEndoTM Linear Cutting Stapler and Loading Units for Single Use, easyEndoTM Universal Linear Cutting Stapler and Loading Units for Single Use?

The FDA 510(k) record lists Ezisurg Medical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for easyEndoTM Linear Cutting Stapler and Loading Units for Single Use, easyEndoTM Universal Linear Cutting Stapler and Loading Units for Single Use?

The FDA product code for easyEndoTM Linear Cutting Stapler and Loading Units for Single Use, easyEndoTM Universal Linear Cutting Stapler and Loading Units for Single Use is GDW.

Other records listing Ezisurg Medical Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K210909easyEndo Lite Linear Cutting Stapler and Loading Unit for Single Use K183477easyPPHTM Hemorrhoidal Stapler for Single Use K181657easyLCTM Linear Cutter Staplers and Loading Units fot Single Use; easyCSTM Circular Stapler for Single Use

Related Devices (Code: GDW)

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.