Stackhouse Freedomaire II Surgical Helmet System, Models 12000, 12010, 12011, 12020, 12021, 12022, 12030, 12031

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K043004 ↗

FDA Product Code

FYA

Models / Variants

12000

12010

12011

12020

12021

12022

12030

12031

Device Class

Class II

Regulation

21 CFR Part 878.4040

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

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