FDA.reportPublic FDA data

510(k) K240657

Device
ArtiSential Laparoscopic Instruments-Electrodes (AMHD01-LH); ArtiSential Laparoscopic Instruments-Electrodes (AMHD01S-LH); ArtiSential Laparoscopic Instruments-Electrodes (AMHD01L-LH); ArtiSential Laparoscopic Instruments-Electrodes (5AMHD01-LH); Art
Applicant
Livsmed, Inc.
510(k) number
K240657
Product code
GEI
Decision
Substantially Equivalent (SESE)
Decision date
2024-06-06
Date received
2024-03-08
Regulation
878.4400
Classification name
Electrosurgical, Cutting & Coagulation & Accessories
Medical specialty
General, Plastic Surgery
Review panel
General, Plastic Surgery
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Hyeonbin Chung
Address
304, D-Dong, 700, Pangyo-Ro, Bundang-Gu Seongnam-Si KR 13516 13516

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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