Storz Ultra-Source High Output Illuminator

No FDA recalls on record, checked 11 Oct 2026.

510(k) Number

K904616 ↗

FDA Product Code

HBI

Device Class

Class II

Regulation

21 CFR Part 878.4580

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

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• Storz Premiere/Premiere Microvit Microsurg Systems

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