FDA 510(k)

Device Electrosurgical Generator ESG-150

Numéro K : K182587 · 2018-11-29

Date de décision2018-11-29

Code produitGEI

Comité consultatifSU

DécisionSubstantially Equivalent

Résumé du dispositif

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.

Questions fréquentes

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.

Essais cliniques associés

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Source officielle

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