GTK Trocars

Laparoscope, General & Plastic Surgery

Guangzhou TK Medical Instrument Co., Ltd.

The following data is part of a premarket notification filed by Guangzhou Tk Medical Instrument Co., Ltd. with the FDA for Gtk Trocars.

Pre-market Notification Details

Device IDK193272
510k NumberK193272
Device Name:GTK Trocars
ClassificationLaparoscope, General & Plastic Surgery
Applicant Guangzhou TK Medical Instrument Co., Ltd. A601, Guangzhou International Business Incubator, Guangzhou Science Park Guangzhou,  CN 510663
ContactTracy Weng
CorrespondentElly Xu
Shenzhen Joyantech Consulting Co., Ltd NO. 55 Shizhou Middle Road , Nanshan District Shenzhen,  CN 518000
Product CodeGCJ  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-11-26
Decision Date2020-07-09

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