FDA 510(k)

Instrumentos Laparoscópicos ArtiSential-Electrodos

N.º K: K230539 · 2023-04-27

Fecha de decisión2023-04-27

Código de productoGEI

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

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 2023-04-27 under 510(k) number K230539. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the ArtiSential Laparoscopic Instruments-Electrodes?

ArtiSential Laparoscopic Instruments-Electrodes is a medical device that received FDA 510(k) clearance on 2023-04-27. The listed applicant is Livsmed, Inc.. The 510(k) number is K230539.

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

ArtiSential Laparoscopic Instruments-Electrodes received FDA 510(k) clearance on 2023-04-27, under 510(k) number K230539.

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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Fuente oficial

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