FDA 510(k)

Disposable Anorectal Staplers, Disposable Intraluminal Staplers, Disposable Linear Cutting Staplers, Disposable Endoscopic Cutting Staplers

K-Number: K211458 · 2021-12-30

ApplicantNingbo Verykind Medical Device Co., Ltd.

Decision Date2021-12-30

Product CodeGDW

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Disposable Anorectal Staplers, Disposable Intraluminal Staplers, Disposable Linear Cutting Staplers, Disposable Endoscopic Cutting Staplers is the device name listed in this FDA 510(k) record. The listed applicant is Ningbo Verykind Medical Device Co., Ltd.. It received FDA 510(k) clearance on 2021-12-30 under 510(k) number K211458. 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 Disposable Anorectal Staplers, Disposable Intraluminal Staplers, Disposable Linear Cutting Staplers, Disposable Endoscopic Cutting Staplers?

Disposable Anorectal Staplers, Disposable Intraluminal Staplers, Disposable Linear Cutting Staplers, Disposable Endoscopic Cutting Staplers is a medical device that received FDA 510(k) clearance on 2021-12-30. The listed applicant is Ningbo Verykind Medical Device Co., Ltd.. The 510(k) number is K211458.

When did Disposable Anorectal Staplers, Disposable Intraluminal Staplers, Disposable Linear Cutting Staplers, Disposable Endoscopic Cutting Staplers receive FDA 510(k) clearance?

Disposable Anorectal Staplers, Disposable Intraluminal Staplers, Disposable Linear Cutting Staplers, Disposable Endoscopic Cutting Staplers received FDA 510(k) clearance on 2021-12-30, under 510(k) number K211458.

Who is the listed applicant for Disposable Anorectal Staplers, Disposable Intraluminal Staplers, Disposable Linear Cutting Staplers, Disposable Endoscopic Cutting Staplers?

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

What is the FDA product code for Disposable Anorectal Staplers, Disposable Intraluminal Staplers, Disposable Linear Cutting Staplers, Disposable Endoscopic Cutting Staplers?

The FDA product code for Disposable Anorectal Staplers, Disposable Intraluminal Staplers, Disposable Linear Cutting Staplers, Disposable Endoscopic Cutting Staplers is GDW.

Other records listing Ningbo Verykind Medical Device 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.

K202709Disposable Powered Endoscopic Linear Cutting Staplers and Cartridges

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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.