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 a medical device manufactured by Genoray Co., Ltd.. It received FDA 510(k) clearance on 2026-04-02 under approval 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. It is manufactured by Genoray Co., Ltd.. The 510(k) number is K252229.
When was BELLIGER ACE approved by the FDA?
BELLIGER ACE received FDA 510(k) clearance on 2026-04-02, under approval number K252229.
What company makes BELLIGER ACE?
BELLIGER ACE is manufactured by Genoray Co., Ltd..
What is the FDA product code for BELLIGER ACE?
The FDA product code for BELLIGER ACE is OWB.
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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.