Model 121 Biopsy Needle, Model 111 Biopsy Needle, Model 112 Biopsy Needle, And Model 131 Disposable Coaxial Biopsy Needle

Instrument, Biopsy

Guangzhou Shengwei Medical Devices Co., Ltd

The following data is part of a premarket notification filed by Guangzhou Shengwei Medical Devices Co., Ltd with the FDA for Model 121 Biopsy Needle, Model 111 Biopsy Needle, Model 112 Biopsy Needle, And Model 131 Disposable Coaxial Biopsy Needle.

Pre-market Notification Details

Device IDK214063
510k NumberK214063
Device Name:Model 121 Biopsy Needle, Model 111 Biopsy Needle, Model 112 Biopsy Needle, And Model 131 Disposable Coaxial Biopsy Needle
ClassificationInstrument, Biopsy
Applicant Guangzhou Shengwei Medical Devices Co., Ltd No. 126, Guangshao Road, Aotou Town Conghua City,  CN 510900
ContactXiaojun Cai
CorrespondentXiaojun Cai
Guangzhou Shengwei Medical Devices Co., Ltd No. 126, Guangshao Road, Aotou Town Conghua City,  CN 510900
Product CodeKNW  
CFR Regulation Number876.1075 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-12-27
Decision Date2022-06-03

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