FDA 510(k)

ShineMed Reloadable Open Cutting Stapler, ShineMed Curved Intraluminal Cutting Stapler

K-Number: K160969 · 2016-12-12

Decision Date2016-12-12

Product CodeGDW

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

ShineMed Reloadable Open Cutting Stapler, ShineMed Curved Intraluminal Cutting Stapler is the device name listed in this FDA 510(k) record. The listed applicant is Shinemed, LLC. It received FDA 510(k) clearance on 2016-12-12 under 510(k) number K160969. 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 ShineMed Reloadable Open Cutting Stapler, ShineMed Curved Intraluminal Cutting Stapler?

ShineMed Reloadable Open Cutting Stapler, ShineMed Curved Intraluminal Cutting Stapler is a medical device that received FDA 510(k) clearance on 2016-12-12. The listed applicant is Shinemed, LLC. The 510(k) number is K160969.

When did ShineMed Reloadable Open Cutting Stapler, ShineMed Curved Intraluminal Cutting Stapler receive FDA 510(k) clearance?

ShineMed Reloadable Open Cutting Stapler, ShineMed Curved Intraluminal Cutting Stapler received FDA 510(k) clearance on 2016-12-12, under 510(k) number K160969.

Who is the listed applicant for ShineMed Reloadable Open Cutting Stapler, ShineMed Curved Intraluminal Cutting Stapler?

The FDA 510(k) record lists Shinemed, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ShineMed Reloadable Open Cutting Stapler, ShineMed Curved Intraluminal Cutting Stapler?

The FDA product code for ShineMed Reloadable Open Cutting Stapler, ShineMed Curved Intraluminal Cutting Stapler is GDW.

Related Devices (Code: GDW)

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.

Official Source

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