Cleared Traditional

External CSF Drainage Ventricular Catheters, External CSF Drainage Lumbar Catheters

K242974 · Sophysa · Neurology

Jun 2025

Decision

267d

Days

Class 2

Risk

About This 510(k) Submission

K242974 is an FDA 510(k) clearance for the External CSF Drainage Ventricular Catheters, External CSF Drainage Lumbar Catheters, a Shunt, Central Nervous System And Components (Class II — Special Controls, product code JXG), submitted by Sophysa (Orsay, FR). The FDA issued a Cleared decision on June 20, 2025, 267 days after receiving the submission on September 26, 2024. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5550.

Submission Details

510(k) Number	K242974 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 26, 2024
Decision Date	June 20, 2025
Days to Decision	267 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF