Ensure Single-Use Coagulation Forceps

Forceps, Biopsy, Electric

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 Ensure Single-use Coagulation Forceps.

Pre-market Notification Details

Device IDK202438
510k NumberK202438
Device Name:Ensure Single-Use Coagulation Forceps
ClassificationForceps, Biopsy, Electric
Applicant Micro-Tech (Nanjing) Co., Ltd. No. 10 Gaoke Thrid Road Nanjing,  CN 210032
ContactCecilia Sun
CorrespondentCecilia Sun
Micro-Tech (Nanjing) Co., Ltd. No. 10 Gaoke Third Road Nanjing,  CN 210032
Product CodeKGE  
CFR Regulation Number876.4300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-08-25
Decision Date2021-03-15
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
16932503548370 K202438 000
16932503548363 K202438 000
16932503548356 K202438 000
16932503548349 K202438 000
16932503548332 K202438 000
16932503548325 K202438 000

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