Cleared Traditional

Sophy Mini Monopressure Valve (SM1)

K250636 · Sophysa · Neurology
Nov 2025
Decision
270d
Days
Class 2
Risk

About This 510(k) Submission

K250636 is an FDA 510(k) clearance for the Sophy Mini Monopressure Valve (SM1), 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 November 28, 2025, 270 days after receiving the submission on March 3, 2025. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5550.

Submission Details

510(k) Number K250636 FDA.gov
FDA Decision Cleared SESE
Date Received March 03, 2025
Decision Date November 28, 2025
Days to Decision 270 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code JXG — Shunt, Central Nervous System And Components
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.5550

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