Product code JXG— Neurology
Smart External Drain (SED) System
- Advisory panel
- Neurology
- Total cleared
- 259
Adverse events under product code JXG
product code JXG- Death
- 76
- Injury
- 5,632
- Malfunction
- 2,230
- Other
- 4
- Total
- 7,942
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code JXG
1–100 of 259- K261004 — Codman® Distal Peritoneal Catheter, Barium Open End (82-1682); Codman® HOLTER® Peritoneal Catheter (SALMON Design) (82-1684)
- K251598 — Intellidrop
- K250636 — Sophy Mini Monopressure Valve (SM1)
- K252514 — EVAC-MRI
- K243531 — Codman Libertís Shunt Catheter with Bactiseal and Endexo Technology
- 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)
- K242974 — External CSF Drainage Ventricular Catheters, External CSF Drainage Lumbar Catheters
- K243205 — EVAC
- K243676 — Duet External Drainage and Monitoring System (EDMS)
- K242003 — XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter Set
- K241458 — Borvo EVAC System (Ergo); Borvo EVAC System (Classic)
- K233445 — Bactiseal Catheters; Bactiseal Barium Striped Catheters; Bactiseal Endoscopic Ventricular Catheter
- K233448 — Bactiseal EVD Catheter Sets; Bactiseal Clear EVD Catheter Set
- K231664 — IRRAflow Active Fluid Exchange System (AFES)
- K221694 — External Drainage System
- K222422 — Polaris Valve Electronic Reading Instrument
- K223330 — Certas Plus Programmable Valves
- K223603 — Reflow System Mini and ReFlow Mini Flusher
- K222471 — IRRAflow Active Fluid Exchange System (AFES)
- K221840 — Hakim Programmable Valves, Hakim Precision Fixed Pressure Valves
- K221918 — ReFlow System Mini
- K212641 — StrataMR II Valves and Shunts
- K200950 — Ventricular Catheter
- K200807 — IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit
- K192266 — M. Blue Adjustable Shunt System
- K192289 — IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit
- K191684 — MoniTorr ICP External Drainage and Monitoring System, LimiTorr Volume Limiting External CSF Drainage System
- K190174 — Miethke Shunt System GAV 2.0 and SA 2.0 Valves
- K182265 — CodMan Certas Plus Programmable Valve
- K181902 — Codman Certas Plus Electronic Tool Kit
- K181622 — StrataMR guider tool
- K171880 — IRRAflow CNS System
- K181301 — Smart External Drain (SED) System
- K172035 — EKOS ultrasound EVD Device, EVD Control Unit
- K172759 — Smart External Drain (SED) System
- K172006 — Alivio Ventricular Catheter and Flusher System (Alivio System)
- K172537 — Codman EDS 3 CSF External Drainage System, Codman EDS 3 CSF External Drainage System Collection Bag
- K172022 — CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled)
- K170599 — SureFlo EVD Catheter
- K171586 — Smart External Drain (SED) System
- K161853 — proGAV Programmable Shunt System, proGAV 2.0 Adjustable Shunt System, proSA Adjustable Shunt System
- K162437 — Codman EDS3 CSF External Drainage System
- K161605 — Smart External Drain (SED) System
- K161992 — Horizontal-Vertical Lumbar Valve Systems, Spetzler Lumbar Peritoneal Shunt Systems
- K152700 — StrataMR Valves and Shunts
- K153041 — Bundled Neurological Shunts and Accessories Product Families Labeling Modification to Support MR Conditional Labeling
- K152897 — Integra DP Valve Systems (including Burr Hole Reservoirs and Stainless Steel Connectors), Gravity Compensating Accessory
- K150898 — LiquoGuard 7, LiquoGuard 7 Drainage Set, Lenght 2000mm
- K152152 — Codman Certas Plus Programmable Valve
- K141227 — POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM/POLARIS ADJUSTABLE VALVE WITH SIPHONX
- K141687 — AESCULAP - MEITHKE PROGAV 2.0 ADJUSTABLE SHUNT SYSTEM
- K143111 — Codman Certas Plus Programmable Valve; Codman Certas Toll Kit
- K140722 — INTEGRA FLOW REGULATING VALVE SYSTEMS OSV II MODELS AND INTEGRA FLOW REGULATING VALVE LOW FLOW MODELS
- K121248 — LIQUOGUARD CSF LIQUOGUARD CSF TUBING SET (1500MM) LIQUOGUARD CSF TUBING SET (2000MM) SAFETY CUSHION FOR TUBING SET ATTAC
- K123554 — SHUNTCHECK
- K123524 — MEDTRONIC STRATA NSC LUMBOPERITONEAL VALVE AND SHUNT SYSTEM
- K122118 — HAKIM PROGRAMMABLE AND PRECISION VALVE SHUNT SYSTEM
- K120559 — AESCULAP-MEITHKE PROSA ADJUSTABLE SHUNT SYSTEM
- K113526 — CODMAN CERTAS PROGRAMMABLE VALVE SYSTEM
- K110560 — MEDTRONIC ARES ANTIBIOTIC-IMPREGNATED CATHETER
- K110206 — AESCULAP- MEITHKE SHUNT SYSTEM
- K112156 — CODMAN CERTAS PROGRAMMABLE VALVE SYSTEM, CODMAN CERTAS THERAPY MANAGEMENT SYSTEM
- K101381 — HORIZONTAL-VERTICAL LUMBAR VALVE AND SPETZLER LUMBAR PERITONEAL SHUNT SYSTEMS
- K110751 — CODMAN BACTISEAL ENDOSCOPIC VENTICULAR CATHETER
- K102961 — HOLTER IN-LINE SHUNT FILTER, HOLTER CEREBRAL CATHETER RESERVOIR, ACCU-FLO CONNECTORS; ACCU-FLO THREE WAY CONNECTOR; CODM
- K102589 — CODMAN BACTISEAL CATHETERS, CODMAN BACTISEAL EVD CATHETER
- K103003 — AESCULAP- MEITHKE PROGAV PROGRAMMABLE SHUNT SYSTEM
- K091328 — SIPHONX GRAVITATIONAL ANTISIPHON DEVICE
- K093968 — OSV II LOW FLOW LOW PRO VALVE
- K092395 — OSV II LUMBAR VALVE SYSTEM AND OSV II LOW FLOW LUMBAR VALVE SYSTEM
- K091312 — PS MEDICAL STRATA NSC LUMBOPERITONEAL VALVE AND SHUNT SYSTEM
- K090342 — POLARIS PRESSURE ADJUSTABLE VALVE, MODELS SPV, SPVA, SPVB, SPV-140, SPV-300, SPV-400
- K091346 — CODMAN HAKIM MICRO II VALVE
- K090348 — CODMAN BACTISEAL EVD CATHETER SET, CODMAN BACTISEAL CLEAR EVD CATHETER SET
- K083076 — STRATA BURR HOLE VALVE, MODEL 42836 AND STRATA BURR HOLE SHUNT ASSEMBLY, MODEL 46836
- K081773 — OSV II
- K082127 — STRATA NSC BURR HOLE VALVE, MODEL 42335; SHUNT ASSEMBLY, MODEL 46635
- K081942 — NEUROCATH AG
- K080168 — SHUNTCHECK - CSF SHUNT FLOW DETECTOR
- K073139 — SMALL LUMEN PERITONEAL CATHETER
- K072929 — LIMITORR VOLUME LIMITING EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM, MODELS INS9020, INS9030
- K063836 — RIVULET VENTRICULAR AND SNAP SHUNT AND CONVERTIBLE VENTRICULAR CATHETERS, MODELS 41701 AND 41704-41715
- K062009 — AESCULAP-MEITHKE PROGAV PROGRAMMABLE VALVE, MODELS FV410T-FV451T
- K061876 — CODMAN VPV SYSTEM, MODEL 82-3192
- K061568 — CODMAN EDS 3 CSF EXTERNAL DRAINAGE SYSTEM, MODELS 82-1730, 82-1731, 82-1732, 82-1733, 82-1735, 82-1738
- K062599 — MONITORR ICP EXTERNAL DRAINAGE AND MONITORING SYSTEMS
- K060681 — MEDTRONIC PS MEDICAL STRATA TYPE VALUE
- K053107 — CODMAN HAKIM PROGRAMMABLE VALVE W/WO SIPHONGUARD
- K053350 — MODIFICATION TO CODMAN HAKIM SHUNT SYSTEMS
- K052386 — MEDTRONIC M2 MAGNET ADJUSTMENT TOOL
- K050739 — CODMAN VPV SYSTEM, MODEL 82-3192
- K041992 — MEDTRONIC STRATAVARIUS
- K042825 — ACCUDRAIN EXTERNAL CSF DRAINAGE SYSTEM
- K042481 — POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM, MODELS SPV-140, SPV-300, SPV-400
- K042359 — SUBDURAL EVACUATING PORT SYSTEM CRANIAL ACCESS KIT (SEPS-CA), (SEPS-CAL), (SEPS-CAND),MODELS 11-0401 CA, 11-0401-CAL
- K040021 — SHUNTCHECK (PROMETHEUS 1)
- K042465 — PS MEDICAL STRATA II VALVE
- K042558 — EQUI-FLOW VALVE AND SHUNT SYSTEM
- K042198 — PS MEDICAL NEUROSURGICAL IMPLANTS
- K042192 — LOW FLOW OSV II HYDROCEPHALUS VALVE
Data sourced from openFDA. This site is unofficial and independent of the FDA.