FDA 510(k)

Electrosurgical Generator ESG-400, Foot Switches, POWERSEAL Curved Jaw Sealer and Divider, Double Action

K-Number: K203682 · 2021-05-17

Decision Date2021-05-17

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Electrosurgical Generator ESG-400, Foot Switches, POWERSEAL Curved Jaw Sealer and Divider, Double Action 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 2021-05-17 under 510(k) number K203682. 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-400, Foot Switches, POWERSEAL Curved Jaw Sealer and Divider, Double Action?

Electrosurgical Generator ESG-400, Foot Switches, POWERSEAL Curved Jaw Sealer and Divider, Double Action is a medical device that received FDA 510(k) clearance on 2021-05-17. The listed applicant is Olympus Winter & Ibe GmbH. The 510(k) number is K203682.

When did Electrosurgical Generator ESG-400, Foot Switches, POWERSEAL Curved Jaw Sealer and Divider, Double Action receive FDA 510(k) clearance?

Electrosurgical Generator ESG-400, Foot Switches, POWERSEAL Curved Jaw Sealer and Divider, Double Action received FDA 510(k) clearance on 2021-05-17, under 510(k) number K203682.

Who is the listed applicant for Electrosurgical Generator ESG-400, Foot Switches, POWERSEAL Curved Jaw Sealer and Divider, Double Action?

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-400, Foot Switches, POWERSEAL Curved Jaw Sealer and Divider, Double Action?

The FDA product code for Electrosurgical Generator ESG-400, Foot Switches, POWERSEAL Curved Jaw Sealer and Divider, Double Action is GEI.

Other records listing Olympus Winter & Ibe GmbH as applicant

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.