Spectra Platinum Mini

by Uzinmedicare South Korea 510(k)

510(k) K260956

Product code HGX

Regulatory status

as of 24 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK260956	Date4 Jun 2026Cleared	StatusActive

Coverage

1 jurisdiction

Active
Not covered

United States — FDA 510(k) Active

Recalls: none on record (FDA, checked 22 Oct 2026)

Specification

510(k) · synced 22 Oct 2026

510(k) Number: K260956
FDA Product Code: HGX
FDA applicant: Uzinmedicare Co., Ltd.

Device Class: Class II
Regulation: 21 CFR Part 884.5160
Advisory Committee: Obstetrics/Gynecology
FDA Decision: SESE Substantially Equivalent

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Properties & raw data

Show properties, registry sources and raw records

Sources (1)

FDA 510(k) K260956 24 fields · synced 22 Oct 2026