NEW DOUBLO 2.0
K-Number: K251334 · 2025-09-29
ApplicantHironic Co., Ltd.
Decision Date2025-09-29
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
NEW DOUBLO 2.0 is a medical device manufactured by Hironic Co., Ltd.. It received FDA 510(k) clearance on 2025-09-29 under approval number K251334. 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 NEW DOUBLO 2.0?
NEW DOUBLO 2.0 is a medical device that received FDA 510(k) clearance on 2025-09-29. It is manufactured by Hironic Co., Ltd.. The 510(k) number is K251334.
When was NEW DOUBLO 2.0 approved by the FDA?
NEW DOUBLO 2.0 received FDA 510(k) clearance on 2025-09-29, under approval number K251334.
What company makes NEW DOUBLO 2.0?
NEW DOUBLO 2.0 is manufactured by Hironic Co., Ltd..
What is the FDA product code for NEW DOUBLO 2.0?
The FDA product code for NEW DOUBLO 2.0 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.