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

Staple, Implantable

Ningbo VeryKind Medical Device Co., Ltd.

The following data is part of a premarket notification filed by Ningbo Verykind Medical Device Co., Ltd. with the FDA for Disposable Anorectal Staplers, Disposable Intraluminal Staplers, Disposable Linear Cutting Staplers, Disposable Endoscopic Cutting Staplers.

Pre-market Notification Details

Device IDK211458
510k NumberK211458
Device Name:Disposable Anorectal Staplers, Disposable Intraluminal Staplers, Disposable Linear Cutting Staplers, Disposable Endoscopic Cutting Staplers
ClassificationStaple, Implantable
Applicant Ningbo VeryKind Medical Device Co., Ltd. #100 Jinghua Road, High-tech Industrial Development Zone Ningbo,  CN 315040
ContactPengfei Hong
CorrespondentDiana Hong
Mid-Link Consulting Co., Ltd P.O.BOX 120-119 Shanghai,  CN 200120
Product CodeGDW  
CFR Regulation Number878.4750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-05-11
Decision Date2021-12-30

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