FDA 510(k)

KOWA FM-600

K-Number: K261255 · 2026-09-11

ApplicantKowa Company, Ltd. Chofu Factory

Decision Date2026-09-11

Product CodeMYC

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

KOWA FM-600 is the device name listed in this FDA 510(k) record. The listed applicant is Kowa Company, Ltd. Chofu Factory. It received FDA 510(k) clearance on 2026-09-11 under 510(k) number K261255. The device is classified under product code MYC. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KOWA FM-600?

KOWA FM-600 is a medical device that received FDA 510(k) clearance on 2026-09-11. The listed applicant is Kowa Company, Ltd. Chofu Factory. The 510(k) number is K261255.

When did KOWA FM-600 receive FDA 510(k) clearance?

KOWA FM-600 received FDA 510(k) clearance on 2026-09-11, under 510(k) number K261255.

Who is the listed applicant for KOWA FM-600?

The FDA 510(k) record lists Kowa Company, Ltd. Chofu Factory as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KOWA FM-600?

The FDA product code for KOWA FM-600 is MYC.

Related Devices (Code: MYC)

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.

K241931OcuMet Beacon (OCUB100)Ocusciences, Inc.K243504MAIA (AHMACME001)Centervue S.P.A.K213705DRSplusCentervue S.P.A.K211328EIDON FA, EIDON, EIDON AF, EIDON UWFLCentervue S.P.A.K192113DRSplusCentervue S.P.A.K180526EIDON FACentervue S.P.A.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.