Disposable Biopsy Valve

Endoscopic Irrigation/suction System

Zhejiang Chuangxiang Medical Technology Co., LTD.

The following data is part of a premarket notification filed by Zhejiang Chuangxiang Medical Technology Co., Ltd. with the FDA for Disposable Biopsy Valve.

Pre-market Notification Details

Device IDK173758
510k NumberK173758
Device Name:Disposable Biopsy Valve
ClassificationEndoscopic Irrigation/suction System
Applicant Zhejiang Chuangxiang Medical Technology Co., LTD. 301B, No.22, XinYan Road Hanzhou,  CN 311100
ContactLucius Long
CorrespondentLucius Long
Zhejiang Chuangxiang Medical Technology Co., LTD. 301B, No.22, XinYan Road Hanzhou,  CN 311100
Product CodeOCX  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-12-11
Decision Date2018-05-14
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
26970401813548 K173758 000
06970401812585 K173758 000
16970401817150 K173758 000
16970401817174 K173758 000
26970401814361 K173758 000
26970401814071 K173758 000
26970401814057 K173758 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.