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PHASOR HEALTH, LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30165776223016577622PHASOR HEALTH, LLC1N2026-01-018944 Kirby Drive Houston TX US 77054

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2383321940992286K252696LEGACYHBG2025-11-21
2383321125236562K252514EVAC-MRIJXG2025-11-05
2383321605162471K252060GREENHBE2025-10-31
2383321507472259K250505EZ-FIDUCIALSHAW2025-07-09
2383321390519557K243205EVACJXG2025-06-03
2383321901785196K161704Phasor DrillHBE2016-12-01
2383321545842141

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
HBE32025-10-31
JXG22025-11-05
HBG12025-11-21
HAW12025-07-09

PMN#

GREEN

2025-10-31

Phasor Health, LLC

EVAC

2025-06-03

Phasor Health, LLC

GUDID#

PHASOR - Phasor EVAC-MRI is indicated when access to and evacuation of a cranial subacute or chronic hematoma or hygroma is necessary. The Phasor EVAC-MRI system is intended for drainage of subdural fluid accumulations such as hygromas and chronic or subacute hematomas to an external suction reservoir. The Phasor EVAC–MRI system is also intended for draining air and fluids from the subdural space immediately following craniotomy procedures performed to remove a chronic or subacute subdural hematoma. (The device is MRI-conditional for the titanium bolt.)

PHASOR HEALTH LLC

2025-11-24

PHASOR - Phasor EZ-FIDUCIALS™ provide fixed reference points during neurosurgical procedures. The device is composed of 3 items, allsingle-use, provided gamma-sterilized, and placed within the same primary packaging (sealed Tyvek tray within a shelf carton):(1) Screws: Each of the four provided titanium screws is identical, with specific dimensions of each EZ-Fiducials screw as follows:screwhead circular shape screwhead with square-shaped engagement, non-threaded shaft diameter 2.9mm and length 15mm,threaded shaft diameter (major threads) 1.98mm, thread length 5mm; no protective caps are provided, and the screws shouldexclusively be utilized in conjunction with the screwdrivers (manual or EZ-Driver) provided together in the same tray (and withno other screwdriver);(2) Manual Screwdriver: handheld, to be solely used with the screws provided, not intended for use with any other screws;(3) EZ-driver: (electric, handheld, non-rechargeable battery-operated screwdriver, without software, single-use for solelytightening or loosening the provided screws exclusively, not intended for use with any other screws).

PHASOR HEALTH LLC

2025-08-21

PHASOR - Phasor EVAC subdural evacuation system is indicated when access to the subdural space and evacuation of a cranial subacute or chronic hematoma or hygroma is necessary. The EVAC system consists of surgical instruments and accessories used for draining subdural fluid accumulations such as hygromas and liquid-state subdural hematomas to an external suction reservoir without touching the brain. Utilizing a minimally invasive technique, the EVAC system components are designed to promote gradual brain re-expansion by creating a low homogeneous negative pressure throughout the subdural space as fluid is drained to an external suction reservoir.

PHASOR HEALTH LLC

2025-06-04

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