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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 a medical device manufactured by Olympus Winter & Ibe GmbH. It received FDA 510(k) clearance on 2016-05-04 under approval 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. It is manufactured by Olympus Winter & Ibe GmbH. The 510(k) number is K160639.

When was Electrosurgical Generator ESG-200 approved by the FDA?

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

What company makes Electrosurgical Generator ESG-200?

Electrosurgical Generator ESG-200 is manufactured by Olympus Winter & Ibe GmbH.

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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Official Source

View on FDA Database →

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