Disposable Endoscopy Adapter Set

Endoscope Channel Accessory

Yangzhou Fartley Medical Instrument Technology Co., Ltd.

The following data is part of a premarket notification filed by Yangzhou Fartley Medical Instrument Technology Co., Ltd. with the FDA for Disposable Endoscopy Adapter Set.

Pre-market Notification Details

Device IDK220210
510k NumberK220210
Device Name:Disposable Endoscopy Adapter Set
ClassificationEndoscope Channel Accessory
Applicant Yangzhou Fartley Medical Instrument Technology Co., Ltd. Beizhou Road, Lidian Town, Guangling District Yangzhou,  CN 225106
ContactTina Han
CorrespondentEthan Liu
Shanghai Thinkwell Consulting Co., Ltd Room 211/6F, Xinling Road, Minhang District Shanghai,  CN 201100
Product CodeODC  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-01-26
Decision Date2022-06-17

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