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FDA 510(k)

The Oligio

K-Number: K221989 · 2022-10-13

ApplicantWontech Co., Ltd.
Decision Date2022-10-13
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

The Oligio is a medical device manufactured by Wontech Co., Ltd.. It received FDA 510(k) clearance on 2022-10-13 under approval number K221989. 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 The Oligio?

The Oligio is a medical device that received FDA 510(k) clearance on 2022-10-13. It is manufactured by Wontech Co., Ltd.. The 510(k) number is K221989.

When was The Oligio approved by the FDA?

The Oligio received FDA 510(k) clearance on 2022-10-13, under approval number K221989.

What company makes The Oligio?

The Oligio is manufactured by Wontech Co., Ltd..

What is the FDA product code for The Oligio?

The FDA product code for The Oligio is GEI.

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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.

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