Single Use Electrosurgical Knife With Fluid Pump System

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 With Fluid Pump System.

Pre-market Notification Details

Device IDK211172
510k NumberK211172
Device Name:Single Use Electrosurgical Knife With Fluid Pump System
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant Micro-Tech (Nanjing) Co., Ltd. No.10 Gaoke Third Road, Nanjing National Hi-Tech Industrial Development Zone Nanjing,  CN 210032
ContactSally He
CorrespondentBecky Li
Micro-Tech (Nanjing) Co., Ltd. No.10 Gaoke Third Road, Nanjing National Hi-Tech Industrial Development Zone Nanjing,  CN 210032
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-04-19
Decision Date2021-12-17

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