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FDA 510(k)

BELLIGER ACE

K-Number: K252229 · 2026-04-02

ApplicantGenoray Co., Ltd.
Decision Date2026-04-02
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

BELLIGER ACE is the device name listed in this FDA 510(k) record. The listed applicant is Genoray Co., Ltd.. It received FDA 510(k) clearance on 2026-04-02 under 510(k) number K252229. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BELLIGER ACE?

BELLIGER ACE is a medical device that received FDA 510(k) clearance on 2026-04-02. The listed applicant is Genoray Co., Ltd.. The 510(k) number is K252229.

When did BELLIGER ACE receive FDA 510(k) clearance?

BELLIGER ACE received FDA 510(k) clearance on 2026-04-02, under 510(k) number K252229.

Who is the listed applicant for BELLIGER ACE?

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

What is the FDA product code for BELLIGER ACE?

The FDA product code for BELLIGER ACE is OWB.

Other records listing Genoray Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: OWB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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