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FDA 510(k)

HF-cables (resusable)

K-Number: K221522 · 2023-01-19

ApplicantOlympus Winter & Ibe GmbH
Decision Date2023-01-19
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

HF-cables (resusable) is the device name listed in this FDA 510(k) record. The listed applicant is Olympus Winter & Ibe GmbH. It received FDA 510(k) clearance on 2023-01-19 under 510(k) number K221522. 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-cables (resusable)?

HF-cables (resusable) is a medical device that received FDA 510(k) clearance on 2023-01-19. The listed applicant is Olympus Winter & Ibe GmbH. The 510(k) number is K221522.

When did HF-cables (resusable) receive FDA 510(k) clearance?

HF-cables (resusable) received FDA 510(k) clearance on 2023-01-19, under 510(k) number K221522.

Who is the listed applicant for HF-cables (resusable)?

The FDA 510(k) record lists Olympus Winter & Ibe GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HF-cables (resusable)?

The FDA product code for HF-cables (resusable) is GEI.

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Related Devices (Code: 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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