FDA 510(k)

Monopolar Electrode Surgical Instrument

Numéro K : K230650 · 2023-10-12

Date de décision2023-10-12

Code produitGEI

Comité consultatifSU

DécisionSubstantially Equivalent

Résumé du dispositif

Monopolar Electrode Surgical Instrument is the device name listed in this FDA 510(k) record. The listed applicant is Vhmed (Nantong) Co. , Ltd.. It received FDA 510(k) clearance on 2023-10-12 under 510(k) number K230650. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Monopolar Electrode Surgical Instrument?

Monopolar Electrode Surgical Instrument is a medical device that received FDA 510(k) clearance on 2023-10-12. The listed applicant is Vhmed (Nantong) Co. , Ltd.. The 510(k) number is K230650.

When did Monopolar Electrode Surgical Instrument receive FDA 510(k) clearance?

Monopolar Electrode Surgical Instrument received FDA 510(k) clearance on 2023-10-12, under 510(k) number K230650.

Who is the listed applicant for Monopolar Electrode Surgical Instrument?

The FDA 510(k) record lists Vhmed (Nantong) Co. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Monopolar Electrode Surgical Instrument?

The FDA product code for Monopolar Electrode Surgical Instrument is GEI.

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Source officielle

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