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FDA 510(k)

Monopolar Electrode Surgical Instrument

K-Number: K230650 · 2023-10-12

ApplicantVhmed (Nantong) Co. , Ltd.
Decision Date2023-10-12
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by Vhmed (Nantong) Co. , Ltd.. The 510(k) number is K230650.

When was Monopolar Electrode Surgical Instrument approved by the FDA?

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

What company makes Monopolar Electrode Surgical Instrument?

Monopolar Electrode Surgical Instrument is manufactured by Vhmed (Nantong) Co. , Ltd..

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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Official Source

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