FDA 510(k)

Resection Electrodes with HF cable

K-Number: K210651 · 2021-08-03

Decision Date2021-08-03

Product CodeFAS

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

Resection Electrodes with HF cable 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 2021-08-03 under 510(k) number K210651. The device is classified under product code FAS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Resection Electrodes with HF cable?

Resection Electrodes with HF cable is a medical device that received FDA 510(k) clearance on 2021-08-03. The listed applicant is Olympus Winter & Ibe GmbH. The 510(k) number is K210651.

When did Resection Electrodes with HF cable receive FDA 510(k) clearance?

Resection Electrodes with HF cable received FDA 510(k) clearance on 2021-08-03, under 510(k) number K210651.

Who is the listed applicant for Resection Electrodes with HF cable?

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 Resection Electrodes with HF cable?

The FDA product code for Resection Electrodes with HF cable is FAS.

Other records listing Olympus Winter & Ibe GmbH as applicant

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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.