Veress Needle

Pneumoperitoneum Needle

WickiMed (Huizhou) Medical Equipment Manufacturing Co.,Ltd.

The following data is part of a premarket notification filed by Wickimed (huizhou) Medical Equipment Manufacturing Co.,ltd. with the FDA for Veress Needle.

Pre-market Notification Details

Device IDK172120
510k NumberK172120
Device Name:Veress Needle
ClassificationPneumoperitoneum Needle
Applicant WickiMed (Huizhou) Medical Equipment Manufacturing Co.,Ltd. Tang Jiao Wang Street, Lilin Town, Zhongkai Hi-Tech Zone Huizhou,  CN 516000
ContactHaobin Li
CorrespondentHaobin Li
WickiMed (Huizhou) Medical Equipment Manufacturing Co.,Ltd. Tang Jiao Wang Street, Lilin Town, Zhongkai Hi-Tech Zone Huizhou,  CN 516000
Product CodeFHO  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-07-13
Decision Date2017-09-14
Summary:summary

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