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FDA 510(k)

HF Surgery Generator 400KHZ

K-Number: K230194 · 2023-03-22

ApplicantRichard Wolf Medical Instruments Corporation
Decision Date2023-03-22
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

HF Surgery Generator 400KHZ is a medical device manufactured by Richard Wolf Medical Instruments Corporation. It received FDA 510(k) clearance on 2023-03-22 under approval number K230194. 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 HF Surgery Generator 400KHZ?

HF Surgery Generator 400KHZ is a medical device that received FDA 510(k) clearance on 2023-03-22. It is manufactured by Richard Wolf Medical Instruments Corporation. The 510(k) number is K230194.

When was HF Surgery Generator 400KHZ approved by the FDA?

HF Surgery Generator 400KHZ received FDA 510(k) clearance on 2023-03-22, under approval number K230194.

What company makes HF Surgery Generator 400KHZ?

HF Surgery Generator 400KHZ is manufactured by Richard Wolf Medical Instruments Corporation.

What is the FDA product code for HF Surgery Generator 400KHZ?

The FDA product code for HF Surgery Generator 400KHZ is GEI.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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