Sophy Mini Monopressure Valve (SM1)— 510(k) K250636

Substantially Equivalent

Sophysa

FDA 510(k) clearance K250636 for Sophy Mini Monopressure Valve (SM1), Substantially Equivalent on 2025-11-28. Applicant: Sophysa.

Clearance details

Applicant: Sophysa
Product code: Code JXG
Advisory panel: Neurology
Date received: 2025-03-03
Decision date: 2025-11-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Orsay, FR

Download summary PDF View on FDA.gov ↗

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, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.