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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Hironic Co., Ltd.. It received FDA 510(k) clearance on 2025-09-29 under 510(k) 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. The listed applicant is Hironic Co., Ltd.. The 510(k) number is K251334.

When did NEW DOUBLO 2.0 receive FDA 510(k) clearance?

NEW DOUBLO 2.0 received FDA 510(k) clearance on 2025-09-29, under 510(k) number K251334.

Who is the listed applicant for NEW DOUBLO 2.0?

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

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.

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