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FDA 510(k)

Device Electrosurgical Generator ESG-150

K-Number: K182587 · 2018-11-29

ApplicantOlympus Winter & Ibe GmbH
Decision Date2018-11-29
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Device Electrosurgical Generator ESG-150 is a medical device manufactured by Olympus Winter & Ibe GmbH. It received FDA 510(k) clearance on 2018-11-29 under approval number K182587. 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 Device Electrosurgical Generator ESG-150?

Device Electrosurgical Generator ESG-150 is a medical device that received FDA 510(k) clearance on 2018-11-29. It is manufactured by Olympus Winter & Ibe GmbH. The 510(k) number is K182587.

When was Device Electrosurgical Generator ESG-150 approved by the FDA?

Device Electrosurgical Generator ESG-150 received FDA 510(k) clearance on 2018-11-29, under approval number K182587.

What company makes Device Electrosurgical Generator ESG-150?

Device Electrosurgical Generator ESG-150 is manufactured by Olympus Winter & Ibe GmbH.

What is the FDA product code for Device Electrosurgical Generator ESG-150?

The FDA product code for Device Electrosurgical Generator ESG-150 is GEI.

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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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