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Phasor Evac

by Phasor Health, LLC

Phasor Evac is a Class II device made by Phasor Health, LLC, cleared under FDA 510(k) K243205 on 3 Jun 2025 and listed in FDA GUDID since 4 Jun 2025 (UDI-DI B775EVAC0), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K243205

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberB775EVAC0 UDI-DI Date4 Jun 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK243205 Date3 Jun 2025DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K243205 decided 3 Jun 2025 Active
  • FDA GUDID UDI-DI B775EVAC0 listed 4 Jun 2025 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K243205
  2. Listed FDA GUDID B775EVAC0

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Phasor
Generic name
Cerebrospinal fluid external drainage kit
Model / reference
EVAC
Primary DI / UDI-DI
B775EVAC0
510(k) Number
FDA product code
JXG
GMDN term
Cerebrospinal fluid external drainage kit
Device class
Class II
Regulation number
882.5550
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Related devices

Category: Cerebrospinal fluid external drainage kit

Similar devices

Also classified as Cerebrospinal fluid external drainage kit.

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See all devices from Phasor Health, LLC →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (8, all answered No)