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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 the device name listed in this FDA 510(k) record. The listed applicant is Wontech Co., Ltd.. It received FDA 510(k) clearance on 2025-01-21 under 510(k) 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. The listed applicant is Wontech Co., Ltd.. The 510(k) number is K243929.

When did Oligio X receive FDA 510(k) clearance?

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

Who is the listed applicant for Oligio X?

The FDA 510(k) record lists Wontech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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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