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FDA 510(k)

Oligio X

K-Number: K243929 · 2025-01-21

ApplicantWontech Co., Ltd.
Decision Date2025-01-21
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Oligio X is a medical device manufactured by Wontech Co., Ltd.. It received FDA 510(k) clearance on 2025-01-21 under approval number K243929. 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 Oligio X?

Oligio X is a medical device that received FDA 510(k) clearance on 2025-01-21. It is manufactured by Wontech Co., Ltd.. The 510(k) number is K243929.

When was Oligio X approved by the FDA?

Oligio X received FDA 510(k) clearance on 2025-01-21, under approval number K243929.

What company makes Oligio X?

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

What is the FDA product code for Oligio X?

The FDA product code for Oligio X 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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