ArtiSential Laparoscopic Instrument-Electrodes

Electrosurgical, Cutting & Coagulation & Accessories

LivsMed Inc.

The following data is part of a premarket notification filed by Livsmed Inc. with the FDA for Artisential Laparoscopic Instrument-electrodes.

Pre-market Notification Details

Device IDK200501
510k NumberK200501
Device Name:ArtiSential Laparoscopic Instrument-Electrodes
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant LivsMed Inc. #304, D-dong, 700, Pangyo-ro, Bundang-gu Seongnam-si,  KR 13516
ContactDong Wook Lee
CorrespondentDong Wook Lee
LivsMed Inc. #304, D-dong, 700, Pangyo-ro, Bundang-gu Seongnam-si,  KR 13516
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-02-28
Decision Date2020-05-11

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08800042700805 K200501 000
08800042700775 K200501 000
08800042700744 K200501 000
08800042700737 K200501 000
08800042700713 K200501 000
08800042700553 K200501 000
08800042700546 K200501 000
08800042700720 K200501 000
08800042700645 K200501 000

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