FDA.report

510(k) K221694

Device
External Drainage System
Applicant
Jmed(Shenzhen) Technology Limited
510(k) number
K221694
Product code
JXG
Decision
Substantially Equivalent (SESE)
Decision date
2023-02-09
Date received
2022-06-10
Regulation
882.5550
Classification name
Shunt, Central Nervous System And Components
Medical specialty
Neurology
Review panel
Neurology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Anna Xiao
Address
7#401, Zhongxing Rd., Xiuxin Community, Kengzi St., Pingshan District Shenzhen City CN 518122 518122

FDA Registration Numbers

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code JXG

510(k)DeviceApplicantDecision date
K251598IntellidropBrainspace, Inc.2025-12-10
K250636Sophy Mini Monopressure Valve (SM1)Sophysa2025-11-28
K252514EVAC-MRIPhasor Health, LLC2025-11-05
K243531Codman Libertís Shunt Catheter with Bactiseal and Endexo TechnologyIntegra Lifesciences Production Corporation2025-08-08
K243552Codman Libertís™ 1.5 mm EVD Catheter with Bactiseal® and Endexo® Technology with Luer Connection (821761); Codman Libertís™ 1.9 mm EVD Catheter with Bactiseal® and Endexo® Technology with Luer Connection (821762)Integra Lifesciences Production Corporation2025-08-06
K242974External CSF Drainage Ventricular Catheters, External CSF Drainage Lumbar CathetersSophysa2025-06-20
K243205EVACPhasor Health, LLC2025-06-03
K243676Duet External Drainage and Monitoring System (EDMS)Medtronic Neurosurgery2025-03-10
K242003XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter SetAesculap, Inc.2024-12-16
K241458Borvo EVAC System (Ergo); Borvo EVAC System (Classic)Borvo Medical, Inc.2024-08-20
K233445Bactiseal Catheters; Bactiseal Barium Striped Catheters; Bactiseal Endoscopic Ventricular CatheterIntegra Lifesciences Production Corporation2024-01-17
K233448Bactiseal EVD Catheter Sets; Bactiseal Clear EVD Catheter SetIntegra Lifesciences Production Corporation2023-12-19
K231664IRRAflow Active Fluid Exchange System (AFES)Irras USA, Inc.2023-10-19
K222422Polaris Valve Electronic Reading InstrumentSophysa2023-02-02
K223330Certas Plus Programmable ValvesIntegra Lifesciences Production Corporation2023-02-01