FDA 510(k)

ArtiSential Laparoscopic Instruments-Electrodes

K-번호: K230498 · 2023-06-05

결정일2023-06-05

제품 코드GEI

자문 위원회SU

결정Substantially Equivalent

기기 요약

ArtiSential Laparoscopic Instruments-Electrodes is the device name listed in this FDA 510(k) record. The listed applicant is Livsmed, Inc.. It received FDA 510(k) clearance on 2023-06-05 under 510(k) number K230498. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the ArtiSential Laparoscopic Instruments-Electrodes?

ArtiSential Laparoscopic Instruments-Electrodes is a medical device that received FDA 510(k) clearance on 2023-06-05. The listed applicant is Livsmed, Inc.. The 510(k) number is K230498.

When did ArtiSential Laparoscopic Instruments-Electrodes receive FDA 510(k) clearance?

ArtiSential Laparoscopic Instruments-Electrodes received FDA 510(k) clearance on 2023-06-05, under 510(k) number K230498.

Who is the listed applicant for ArtiSential Laparoscopic Instruments-Electrodes?

The FDA 510(k) record lists Livsmed, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ArtiSential Laparoscopic Instruments-Electrodes?

The FDA product code for ArtiSential Laparoscopic Instruments-Electrodes is GEI.

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