JXG — Shunt, Central Nervous System And Components Class II
FDA Device Classification
Classification Details
- Product Code
- JXG
- Device Class
- Class II
- Regulation Number
- 882.5550
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Neurology
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K251598 | brainspace | Intellidrop | December 10, 2025 |
| K250636 | sophysa | Sophy Mini Monopressure Valve (SM1) | November 28, 2025 |
| K252514 | phasor health | EVAC-MRI | November 5, 2025 |
| K243531 | integra lifesciences production corporation | Codman Libertís Shunt Catheter with Bactiseal and Endexo Technology | August 8, 2025 |
| K243552 | integra lifesciences production corporation | Codman Libertís 1.5 mm EVD Catheter with Bactiseal® and Endexo® Technology with | August 6, 2025 |
| K242974 | sophysa | External CSF Drainage Ventricular Catheters, External CSF Drainage Lumbar Cathet | June 20, 2025 |
| K243205 | phasor health | EVAC | June 3, 2025 |
| K243676 | medtronic neurosurgery | Duet External Drainage and Monitoring System (EDMS) | March 10, 2025 |
| K242003 | aesculap | XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter Set | December 16, 2024 |
| K241458 | borvo medical | Borvo EVAC System (Ergo); Borvo EVAC System (Classic) | August 20, 2024 |
| K233445 | integra lifesciences production corporation | Bactiseal Catheters; Bactiseal Barium Striped Catheters; Bactiseal Endoscopic Ve | January 17, 2024 |
| K233448 | integra lifesciences production corporation | Bactiseal EVD Catheter Sets; Bactiseal Clear EVD Catheter Set | December 19, 2023 |
| K231664 | irras usa | IRRAflow Active Fluid Exchange System (AFES) | October 19, 2023 |
| K221694 | jmed(shenzhen) technology limited | External Drainage System | February 9, 2023 |
| K222422 | sophysa | Polaris Valve Electronic Reading Instrument | February 2, 2023 |
| K223330 | integra lifesciences production corporation | Certas Plus Programmable Valves | February 1, 2023 |
| K223603 | anuncia medical | Reflow System Mini and ReFlow Mini Flusher | December 29, 2022 |
| K222471 | irras usa | IRRAflow Active Fluid Exchange System (AFES) | December 8, 2022 |
| K221840 | integra lifesciences production corporation | Hakim Programmable Valves, Hakim Precision Fixed Pressure Valves | October 14, 2022 |
| K221918 | anuncia medical | ReFlow System Mini | September 29, 2022 |