FDA 510(k)

HF-cables (resusable)

K-Number: K221522 · 2023-01-19

Decision Date2023-01-19

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

HF-cables (resusable) is a medical device manufactured by Olympus Winter & Ibe GmbH. It received FDA 510(k) clearance on 2023-01-19 under approval 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. It is manufactured by Olympus Winter & Ibe GmbH. The 510(k) number is K221522.

When was HF-cables (resusable) approved by the FDA?

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

What company makes HF-cables (resusable)?

HF-cables (resusable) is manufactured by Olympus Winter & Ibe GmbH.

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

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

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Official Source

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