Andorate Auxiliary Water Connector

Endoscopic Irrigation/suction System

Smartdata Suzhou Co., Ltd

The following data is part of a premarket notification filed by Smartdata Suzhou Co., Ltd with the FDA for Andorate Auxiliary Water Connector.

Pre-market Notification Details

Device IDK182998
510k NumberK182998
Device Name:Andorate Auxiliary Water Connector
ClassificationEndoscopic Irrigation/suction System
Applicant Smartdata Suzhou Co., Ltd 4f, Block 7, 198#, Jinshan Rd Suzhou,  CN 215011
ContactCindy Ye
CorrespondentDave Yungvirt
THIRD PARTY REVIEW GROUP, LLC 25 Independence Blvd Warren,  NJ  07059
Product CodeOCX  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2018-10-30
Decision Date2019-04-17

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
30653405986489 K182998 000
10816734022662 K182998 000

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