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FDA 510(k)

Electrosurgical Generator ESG-200

K-Number: K160639 · 2016-05-04

ApplicantOlympus Winter & Ibe GmbH
Decision Date2016-05-04
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Electrosurgical Generator ESG-200 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 2016-05-04 under 510(k) number K160639. 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 Electrosurgical Generator ESG-200?

Electrosurgical Generator ESG-200 is a medical device that received FDA 510(k) clearance on 2016-05-04. The listed applicant is Olympus Winter & Ibe GmbH. The 510(k) number is K160639.

When did Electrosurgical Generator ESG-200 receive FDA 510(k) clearance?

Electrosurgical Generator ESG-200 received FDA 510(k) clearance on 2016-05-04, under 510(k) number K160639.

Who is the listed applicant for Electrosurgical Generator ESG-200?

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 Electrosurgical Generator ESG-200?

The FDA product code for Electrosurgical Generator ESG-200 is GEI.

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Related Devices (Code: GEI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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