Product code JXG
- Device name
- Shunt, Central Nervous System And Components
- Medical specialty
- Neurology
- Device class
- 2
- Regulation number
- 882.5550
- Review panel
- NE
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260044 | Ventricular Catheters, Thomale Catheter | Aesculap, Inc. | 2026-10-02 |
| K261004 | Codman® Distal Peritoneal Catheter, Barium Open End (82-1682); Codman® HOLTER® Peritoneal Catheter (SALMON Design) (82-1684) | Integra Lifesciences Production Corporation | 2026-06-23 |
| K251598 | Intellidrop | Brainspace, Inc. | 2025-12-10 |
| K250636 | Sophy Mini Monopressure Valve (SM1) | Sophysa | 2025-11-28 |
| K252514 | EVAC-MRI | Phasor Health, LLC | 2025-11-05 |
| K243531 | Codman Libertís Shunt Catheter with Bactiseal and Endexo Technology | Integra Lifesciences Production Corporation | 2025-08-08 |
| 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 | 2025-08-06 |
| K242974 | External CSF Drainage Ventricular Catheters, External CSF Drainage Lumbar Catheters | Sophysa | 2025-06-20 |
| K243205 | EVAC | Phasor Health, LLC | 2025-06-03 |
| K243676 | Duet External Drainage and Monitoring System (EDMS) | Medtronic Neurosurgery | 2025-03-10 |
| K242003 | XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter Set | Aesculap, Inc. | 2024-12-16 |
| K241458 | Borvo EVAC System (Ergo); Borvo EVAC System (Classic) | Borvo Medical, Inc. | 2024-08-20 |
| K233445 | Bactiseal Catheters; Bactiseal Barium Striped Catheters; Bactiseal Endoscopic Ventricular Catheter | Integra Lifesciences Production Corporation | 2024-01-17 |
| K233448 | Bactiseal EVD Catheter Sets; Bactiseal Clear EVD Catheter Set | Integra Lifesciences Production Corporation | 2023-12-19 |
| K231664 | IRRAflow Active Fluid Exchange System (AFES) | Irras USA, Inc. | 2023-10-19 |
| K221694 | External Drainage System | Jmed(Shenzhen) Technology Limited | 2023-02-09 |
| K222422 | Polaris Valve Electronic Reading Instrument | Sophysa | 2023-02-02 |
| K223330 | Certas Plus Programmable Valves | Integra Lifesciences Production Corporation | 2023-02-01 |
| K223603 | Reflow System Mini and ReFlow Mini Flusher | Anuncia Medical, Inc. | 2022-12-29 |
| K222471 | IRRAflow Active Fluid Exchange System (AFES) | Irras USA | 2022-12-08 |
| K221840 | Hakim Programmable Valves, Hakim Precision Fixed Pressure Valves | Integra Lifesciences Production Corporation | 2022-10-14 |
| K221918 | ReFlow System Mini | Anuncia Medical, Inc. | 2022-09-29 |
| K212641 | StrataMR II Valves and Shunts | Medtronic Neurosurgery | 2021-09-16 |
| K200950 | Ventricular Catheter | Aesculap, Inc. | 2020-05-08 |
| K200807 | IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit | Irras USA, Inc. | 2020-04-29 |
| K192266 | M. Blue Adjustable Shunt System | Aesculap, Inc. | 2019-11-21 |
| K192289 | IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit | Irras USA, Ltd. | 2019-11-15 |
| K191684 | MoniTorr ICP External Drainage and Monitoring System, LimiTorr Volume Limiting External CSF Drainage System | Integra LifeSciences Corporation | 2019-10-11 |
| K190174 | Miethke Shunt System GAV 2.0 and SA 2.0 Valves | Aesculap, Inc. | 2019-07-05 |
| K182265 | CodMan Certas Plus Programmable Valve | Integra Lifesciences Corp. | 2018-11-20 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10381780536925 | CODMAN® ACCU-FLO® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2024-05-29 |
| 10381780537373 | CODMAN® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2024-05-29 |
| 10381780537380 | CODMAN® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2024-05-29 |
| 10381780541578 | CODMAN® ACCU-FLO® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2024-05-29 |
| 10381780541585 | CODMAN® ACCU-FLO® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2024-05-29 |
| 10381780541738 | CODMAN® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2024-05-29 |
| 10381780541745 | CODMAN® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2024-05-29 |
| 10381780536918 | CODMAN® ACCU-FLO® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2024-05-29 |
| 10381780518679 | CODMAN® HAKIM® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2020-06-02 |
| 10381780518778 | CODMAN® HAKIM® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2020-06-02 |
| 10381780518686 | CODMAN® HAKIM® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2020-06-02 |
| 10381780518693 | CODMAN® HAKIM® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2020-06-02 |
| 10381780518709 | CODMAN® HAKIM® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2020-06-02 |
| 10381780518716 | CODMAN® HAKIM® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2020-06-02 |
| 10381780518723 | CODMAN® HAKIM® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2020-06-02 |
| 10381780518730 | CODMAN® HAKIM® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2020-06-02 |
| 10381780518747 | CODMAN® HAKIM® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2020-06-02 |
| 10381780518754 | CODMAN® HAKIM® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2020-06-02 |
| 10381780518761 | CODMAN® HAKIM® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2020-06-02 |
| 10381780518662 | CODMAN® HAKIM® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2020-06-02 |
| 10381780518600 | CODMAN® HAKIM® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2020-06-02 |
| 10381780518594 | CODMAN® HAKIM® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2020-06-02 |
| 10381780518587 | CODMAN® HAKIM® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2020-06-02 |
| 10381780518570 | CODMAN® HAKIM® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2020-06-02 |
| 10381780518563 | CODMAN® HAKIM® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2020-06-02 |
| 10381780518556 | CODMAN® HAKIM® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2020-06-02 |
| 10381780518549 | CODMAN® HAKIM® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2020-06-02 |
| 10381780518532 | CODMAN® HAKIM® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2020-06-02 |
| 10381780518525 | CODMAN® HAKIM® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2020-06-02 |
| 10381780518518 | CODMAN® HAKIM® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2020-06-02 |