JXG
- Product code
- JXG
- Device name
- Shunt, Central Nervous System And Components
- Device class
- Class 2
- 21 CFR
- 21 CFR 882.5550
- Medical specialty
- Neurology
- Marketing pathway
- 510(K)
- Flag
- Implant
- 510(k) clearances (last 3 years)
- 14
- Summaries archived here
- 13 (direct download)
- 510(k) clearances (all years, FDA)
- 259 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (14)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K261004 | 2026-06-23 | Integra Lifesciences Production Corpor… | Codman® Distal Peritoneal Catheter, Barium Open End … | |
| K251598 | 2025-12-10 | Brainspace, Inc. | Intellidrop | |
| K250636 | 2025-11-28 | Sophysa | Sophy Mini Monopressure Valve (SM1) | |
| K252514 | 2025-11-05 | Phasor Health, LLC | EVAC-MRI | |
| K243531 | 2025-08-08 | Integra Lifesciences Production Corpor… | Codman Libertís Shunt Catheter with Bactiseal and En… | |
| K243552 | 2025-08-06 | Integra Lifesciences Production Corpor… | Codman Libertís 1.5 mm EVD Catheter with Bactiseal®… | |
| K242974 | 2025-06-20 | Sophysa | External CSF Drainage Ventricular Catheters, Externa… | |
| K243205 | 2025-06-03 | Phasor Health, LLC | EVAC | |
| K243676 | 2025-03-10 | Medtronic Neurosurgery | Duet External Drainage and Monitoring System (EDMS) | |
| K242003 | 2024-12-16 | Aesculap, Inc. | XABO Ventricular Catheter, XABO Peritoneal Catheter,… | |
| K241458 | 2024-08-20 | Borvo Medical, Inc. | Borvo EVAC System (Ergo); Borvo EVAC System (Classic… | FDA |
| K233445 | 2024-01-17 | Integra Lifesciences Production Corpor… | Bactiseal Catheters; Bactiseal Barium Striped Cathet… | |
| K233448 | 2023-12-19 | Integra Lifesciences Production Corpor… | Bactiseal EVD Catheter Sets; Bactiseal Clear EVD Cat… | |
| K231664 | 2023-10-19 | Irras USA, Inc. | IRRAflow Active Fluid Exchange System (AFES) |
Official FDA classification page: JXG
Classification and pathway per current FDA publications. Data from openFDA (CC0).