Evac-Mri

FDA 510(k) K252514 · Phasor Health, LLC

Unknown

510(k) numberK252514

Submission

Device name
Evac-Mri
Applicant
Phasor Health, LLC
Houston, TX, US
Received
August 11, 2025
Decision date
November 5, 2025
Decision
Unknown (SESD)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
JXG – Shunt, Central Nervous System And Components
Device class
Class II (moderate risk)
Regulation
21 CFR 882.5550
Specialty
Neurology
Implant
Yes

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Questions and answers

When was Evac-Mri cleared by the FDA?

Evac-Mri (K252514) received a 510(k) decision of Unknown on November 5, 2025, 86 days after the submission was received.

What is the product code of K252514?

The FDA product code is JXG – Shunt, Central Nervous System And Components, a Class II (moderate risk) device regulated under 21 CFR 882.5550.