JXG · Shunt, Central Nervous System And Components
Neurology · 21 CFR 882.5550 · Class 2
Overview
| Product Code | JXG |
|---|---|
| Device Name | Shunt, Central Nervous System And Components |
| Regulation | 21 CFR 882.5550 |
| Device Class | Class 2 |
| Review Panel | Neurology |
| Implant | Yes |
Identification
A central nervous system fluid shunt is a device or combination of devices used to divert fluid from the brain or other part of the central nervous system to an internal delivery site or an external receptacle for the purpose of relieving elevated intracranial pressure or fluid volume (e.g., due to hydrocephalus). Components of a central nervous system shunt include catheters, valved catheters, valves, connectors, and other accessory components intended to facilitate use of the shunt or evaluation of a patient with a shunt.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 258)
Showing 20 most recent of 258 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K251598 | Intellidrop | Brainspace, Inc. | Dec 10, 2025 | SESE |
| K250636 | Sophy Mini Monopressure Valve (SM1) | Sophysa | Nov 28, 2025 | SESE |
| K252514 | EVAC-MRI | Phasor Health, LLC | Nov 5, 2025 | SESD |
| K243531 | Codman Libertís Shunt Catheter with Bactiseal and Endexo Technology | Integra Lifesciences Production Corporation | Aug 8, 2025 | SESE |
| K243552 | Codman 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 Corporation | Aug 6, 2025 | SESE |
| K242974 | External CSF Drainage Ventricular Catheters, External CSF Drainage Lumbar Catheters | Sophysa | Jun 20, 2025 | SESE |
| K243205 | EVAC | Phasor Health, LLC | Jun 3, 2025 | SESE |
| K243676 | Duet External Drainage and Monitoring System (EDMS) | Medtronic Neurosurgery | Mar 10, 2025 | SESE |
| K242003 | XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter Set | Aesculap, Inc. | Dec 16, 2024 | SESE |
| K241458 | Borvo EVAC System (Ergo); Borvo EVAC System (Classic) | Borvo Medical, Inc. | Aug 20, 2024 | SESE |
| K233445 | Bactiseal Catheters; Bactiseal Barium Striped Catheters; Bactiseal Endoscopic Ventricular Catheter | Integra Lifesciences Production Corporation | Jan 17, 2024 | SESE |
| K233448 | Bactiseal EVD Catheter Sets; Bactiseal Clear EVD Catheter Set | Integra Lifesciences Production Corporation | Dec 19, 2023 | SESE |
| K231664 | IRRAflow Active Fluid Exchange System (AFES) | Irras USA, Inc. | Oct 19, 2023 | SESE |
| K221694 | External Drainage System | Jmed(Shenzhen) Technology Limited | Feb 9, 2023 | SESE |
| K222422 | Polaris Valve Electronic Reading Instrument | Sophysa | Feb 2, 2023 | SESE |
| K223330 | Certas Plus Programmable Valves | Integra Lifesciences Production Corporation | Feb 1, 2023 | SESE |
| K223603 | Reflow System Mini and ReFlow Mini Flusher | Anuncia Medical, Inc. | Dec 29, 2022 | SESE |
| K222471 | IRRAflow Active Fluid Exchange System (AFES) | Irras USA | Dec 8, 2022 | SESE |
| K221840 | Hakim Programmable Valves, Hakim Precision Fixed Pressure Valves | Integra Lifesciences Production Corporation | Oct 14, 2022 | SESE |
| K221918 | ReFlow System Mini | Anuncia Medical, Inc. | Sep 29, 2022 | SESE |
Top Applicants
- Codman & Shurtleff, Inc. — 23 clearances
- Holter-Hausner Intl. — 21 clearances
- Cordis Corp. — 18 clearances
- Medtronic Neurosurgery — 18 clearances
- Pudenz-Schulte Medical Research Corp. — 18 clearances
