FDA 510(k)

ArmSure Fluoroscopic Positioning System

K-Number: K251992 · 2026-02-11

Decision Date2026-02-11

Product CodeOWB

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by Savfe Co. , Ltd.. The 510(k) number is K251992.

When was ArmSure Fluoroscopic Positioning System approved by the FDA?

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

What company makes ArmSure Fluoroscopic Positioning System?

ArmSure Fluoroscopic Positioning System is manufactured by Savfe Co. , Ltd..

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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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.