Sophy Mini Monopressure Valve (SM1)— 510(k) K250636
Substantially EquivalentSophysa
FDA 510(k) clearance K250636 for Sophy Mini Monopressure Valve (SM1), Substantially Equivalent on 2025-11-28. Applicant: Sophysa. Device class: 2.
Clearance details
- Applicant
- Sophysa
- Product code
- Code JXG
- Device class
- Class 2
- Regulation
- 21 CFR 882.5550
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Orsay, FR
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More clearances from Sophysa
view allAdverse 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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.