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FDA 510(k)

Spectra Platinum Mini

K-Number: K260956 · 2026-06-04

ApplicantUzinmedicare Co., Ltd.
Decision Date2026-06-04
Product CodeHGX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Spectra Platinum Mini is the device name listed in this FDA 510(k) record. The listed applicant is Uzinmedicare Co., Ltd.. It received FDA 510(k) clearance on 2026-06-04 under 510(k) number K260956. 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 Spectra Platinum Mini?

Spectra Platinum Mini is a medical device that received FDA 510(k) clearance on 2026-06-04. The listed applicant is Uzinmedicare Co., Ltd.. The 510(k) number is K260956.

When did Spectra Platinum Mini receive FDA 510(k) clearance?

Spectra Platinum Mini received FDA 510(k) clearance on 2026-06-04, under 510(k) number K260956.

Who is the listed applicant for Spectra Platinum Mini?

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

What is the FDA product code for Spectra Platinum Mini?

The FDA product code for Spectra Platinum Mini is HGX.

Other records listing Uzinmedicare Co., Ltd. as applicant

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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

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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