Evac

FDA 510(k) K243205 · Phasor Health, LLC

Substantially Equivalent

510(k) numberK243205

Submission

Device name
Evac
Applicant
Phasor Health, LLC
Houston, TX, US
Received
October 1, 2024
Decision date
June 3, 2025
Decision
Substantially Equivalent (SESE)
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

Other 510(k)s with product code JXG

510(k)DeviceApplicantDecision
K261004Codman® Distal Peritoneal Catheter, Barium Open End (82-1682); Codman® HOLTER®…JXG · Traditional Integra Lifesciences Production Corporation06/23/2026SE
K251598IntellidropJXG · Traditional Brainspace, Inc.12/10/2025SE
K250636Sophy Mini Monopressure Valve (SM1)JXG · Traditional Sophysa11/28/2025SE
K252514Evac-MriJXG · Traditional Phasor Health, LLC11/05/2025SESD
K243531Codman Libertís Shunt Catheter with Bactiseal and Endexo TechnologyJXG · Traditional Integra Lifesciences Production Corporation08/08/2025SE
K243552Codman Libertís™ 1.5 mm EVD Catheter with Bactiseal® and Endexo® Technology with Luer…JXG · Traditional Integra Lifesciences Production Corporation08/06/2025SE
K242974External CSF Drainage Ventricular Catheters, External CSF Drainage Lumbar CathetersJXG · Traditional Sophysa06/20/2025SE
K243676Duet External Drainage and Monitoring System (EDMS)JXG · Traditional Medtronic Neurosurgery03/10/2025SE
K242003XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter SetJXG · Traditional Aesculap, Inc.12/16/2024SE
K241458Borvo EVAC System (Ergo); Borvo EVAC System (Classic)JXG · Traditional Borvo Medical, Inc.08/20/2024SE

More from Borvo Medical, Inc.

510(k)DeviceDecision
K252696LegacyHBG · Traditional 11/21/2025SE
K252514Evac-MriJXG · Traditional 11/05/2025SESD
K252060GreenHBE · Traditional 10/31/2025SE
K250505Ez-FiducialsHAW · Traditional 07/09/2025SE

Questions and answers

When was Evac cleared by the FDA?

Evac (K243205) received a 510(k) decision of Substantially Equivalent on June 3, 2025, 245 days after the submission was received.

What is the product code of K243205?

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