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FDA 510(k)

Cimilre Dual Max

K-Number: K260643 · 2026-08-21

ApplicantCimilre Co., Ltd.
Decision Date2026-08-21
Product CodeHGX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Cimilre Dual Max is the device name listed in this FDA 510(k) record. The listed applicant is Cimilre Co., Ltd.. It received FDA 510(k) clearance on 2026-08-21 under 510(k) number K260643. The device is classified under product code HGX. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Cimilre Dual Max?

Cimilre Dual Max is a medical device that received FDA 510(k) clearance on 2026-08-21. The listed applicant is Cimilre Co., Ltd.. The 510(k) number is K260643.

When did Cimilre Dual Max receive FDA 510(k) clearance?

Cimilre Dual Max received FDA 510(k) clearance on 2026-08-21, under 510(k) number K260643.

Who is the listed applicant for Cimilre Dual Max?

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

What is the FDA product code for Cimilre Dual Max?

The FDA product code for Cimilre Dual Max is HGX.

Other records listing Cimilre 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.

K221708CIMILRE Free-T2 PlusK162870CIMLRE F1 and CIMILRE S3

Related Devices (Code: HGX)

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

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

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