Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

External CSF Drainage Ventricular Catheters, External CSF Drainage Lumbar Catheters

K-Number: K242974 · 2025-06-20

ApplicantSophysa
Decision Date2025-06-20
Product CodeJXG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

External CSF Drainage Ventricular Catheters, External CSF Drainage Lumbar Catheters is a medical device manufactured by Sophysa. It received FDA 510(k) clearance on 2025-06-20 under approval number K242974. The device is classified under product code JXG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the External CSF Drainage Ventricular Catheters, External CSF Drainage Lumbar Catheters?

External CSF Drainage Ventricular Catheters, External CSF Drainage Lumbar Catheters is a medical device that received FDA 510(k) clearance on 2025-06-20. It is manufactured by Sophysa. The 510(k) number is K242974.

When was External CSF Drainage Ventricular Catheters, External CSF Drainage Lumbar Catheters approved by the FDA?

External CSF Drainage Ventricular Catheters, External CSF Drainage Lumbar Catheters received FDA 510(k) clearance on 2025-06-20, under approval number K242974.

What company makes External CSF Drainage Ventricular Catheters, External CSF Drainage Lumbar Catheters?

External CSF Drainage Ventricular Catheters, External CSF Drainage Lumbar Catheters is manufactured by Sophysa.

What is the FDA product code for External CSF Drainage Ventricular Catheters, External CSF Drainage Lumbar Catheters?

The FDA product code for External CSF Drainage Ventricular Catheters, External CSF Drainage Lumbar Catheters is JXG.

Related Clinical Trials

NCT06940752 VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms) Using Commercial Off-The-Shelf (COTS) Catheters ENROLLING_BY_INVITATION NCT06253858 Ultrasound (US) Guided External Ventricular Catheter Placement RECRUITING NCT07577739 Noninvasive CA Monitoring Validation and Autonomic Modulation in Aneurysmal Subarachnoid Hemorrhage NOT_YET_RECRUITING NCT07494812 Examining the Feasibility of Using Pressure Gradient Regulated Automated Cerebral Spinal Fluid Drainage During External Lumbar Drain Trials NOT_YET_RECRUITING NCT07233876 DuoCor 2 DOMINATE Study NOT_YET_RECRUITING NCT07201506 Real-Time Intracardiac Echocardiography for Ventricular Arrhythmia Ablation RECRUITING

Other Devices by Sophysa

K222422Polaris Valve Electronic Reading Instrument K250636Sophy Mini Monopressure Valve (SM1) K252241Pressio 3 Multi-parameter Neuromonitoring System

Related Devices (Code: JXG)

K162437Codman EDS3 CSF External Drainage SystemCodman & Shurtleff, Inc. K161605Smart External Drain (SED) SystemAqueduct Critical Care, Inc. K161992Horizontal-Vertical Lumbar Valve Systems, Spetzler Lumbar Peritoneal Shunt SystemsIntegra LifeSciences Corporation K152700StrataMR Valves and ShuntsMedtronic Neurosurgery K153041Bundled Neurological Shunts and Accessories Product Families Labeling Modification to Support MR Conditional LabelingIntegra LifeSciences Corporation K152897Integra DP Valve Systems (including Burr Hole Reservoirs and Stainless Steel Connectors), Gravity Compensating AccessoryIntegra LifeSciences Corporation

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑