FDA 510(k)

ELECTROSUGRICAL RESECTION AND VAPORIZATION ELECTRODE SERIES

K-Number: K120418 · 2012-06-20

Decision Date2012-06-20

Product CodeFAS

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

ELECTROSUGRICAL RESECTION AND VAPORIZATION ELECTRODE SERIES 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 2012-06-20 under 510(k) number K120418. 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 ELECTROSUGRICAL RESECTION AND VAPORIZATION ELECTRODE SERIES?

ELECTROSUGRICAL RESECTION AND VAPORIZATION ELECTRODE SERIES is a medical device that received FDA 510(k) clearance on 2012-06-20. The listed applicant is Olympus Winter & Ibe GmbH. The 510(k) number is K120418.

When did ELECTROSUGRICAL RESECTION AND VAPORIZATION ELECTRODE SERIES receive FDA 510(k) clearance?

ELECTROSUGRICAL RESECTION AND VAPORIZATION ELECTRODE SERIES received FDA 510(k) clearance on 2012-06-20, under 510(k) number K120418.

Who is the listed applicant for ELECTROSUGRICAL RESECTION AND VAPORIZATION ELECTRODE SERIES?

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 ELECTROSUGRICAL RESECTION AND VAPORIZATION ELECTRODE SERIES?

The FDA product code for ELECTROSUGRICAL RESECTION AND VAPORIZATION ELECTRODE SERIES is FAS.

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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.