JXG — Shunt, Central Nervous System And Components Class II
FDA product code JXG covers "Shunt, Central Nervous System And Components", a Class II medical device regulated under 21 CFR 882.5550. Submissions are reviewed by the Neurology panel. Devices under this code are implants. At least 20 recent 510(k) clearances have been granted under this product code.
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 |
|---|---|---|---|
| K261004 | integra lifesciences production corporation | Codman® Distal Peritoneal Catheter, Barium Open End (82-1682); Codman® HOLTER® P | June 23, 2026 |
| 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 |