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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 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 2018-11-29 under 510(k) 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. The listed applicant is Olympus Winter & Ibe GmbH. The 510(k) number is K182587.

When did Device Electrosurgical Generator ESG-150 receive FDA 510(k) clearance?

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

Who is the listed applicant for Device Electrosurgical Generator ESG-150?

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 Device Electrosurgical Generator ESG-150?

The FDA product code for Device Electrosurgical Generator ESG-150 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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