Single Use Electrosurgical Knife

Electrosurgical, Cutting & Coagulation & Accessories

Micro-Tech (Nanjing) Co., Ltd.

The following data is part of a premarket notification filed by Micro-tech (nanjing) Co., Ltd. with the FDA for Single Use Electrosurgical Knife.

Pre-market Notification Details

Device IDK193601
510k NumberK193601
Device Name:Single Use Electrosurgical Knife
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant Micro-Tech (Nanjing) Co., Ltd. No.10 Gaoke Third Road Nanjing,  CN 210032
ContactSally He
CorrespondentSally He
Micro-Tech (Nanjing) Co., Ltd. No.10 Gaoke Third Road Nanjing,  CN 210032
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-23
Decision Date2020-07-24

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.