AutoGel Pad (400-046,400-005)— 510(k) K260575

Name: FDA 510(k) clearance K260575
Creator: U.S. Food and Drug Administration
Published: 2026-10-30

Substantially Equivalent

Top-Rank Health Care Co., Ltd.

FDA 510(k) clearance K260575 for AutoGel Pad (400-046,400-005), Substantially Equivalent on 2026-10-30. Applicant: Top-Rank Health Care Co., Ltd.. Device class: 2.

Clearance details

Applicant: Top-Rank Health Care Co., Ltd.
Product code: Product code MUI
Device class: Class 2
Regulation: 21 CFR 892.1570
Advisory panel: Radiology
Date received: 2026-02-20
Decision date: 2026-10-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shaoxing, CN

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.