FDA 510(k)

ArmSure Fluoroscopic Positioning System

Número K: K251992 · 2026-02-11

Data da decisão2026-02-11

Código do produtoOWB

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

ArmSure Fluoroscopic Positioning System is the device name listed in this FDA 510(k) record. The listed applicant is Savfe Co. , Ltd.. It received FDA 510(k) clearance on 2026-02-11 under 510(k) number K251992. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the ArmSure Fluoroscopic Positioning System?

ArmSure Fluoroscopic Positioning System is a medical device that received FDA 510(k) clearance on 2026-02-11. The listed applicant is Savfe Co. , Ltd.. The 510(k) number is K251992.

When did ArmSure Fluoroscopic Positioning System receive FDA 510(k) clearance?

ArmSure Fluoroscopic Positioning System received FDA 510(k) clearance on 2026-02-11, under 510(k) number K251992.

Who is the listed applicant for ArmSure Fluoroscopic Positioning System?

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

What is the FDA product code for ArmSure Fluoroscopic Positioning System?

The FDA product code for ArmSure Fluoroscopic Positioning System is OWB.

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