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Sophysa

FDA 510(k) & PMA Approved Devices — 4 products

Total Devices4
Categories2
Latest FDA decision2026-04-10
TypeNumberDevice NameCodeDateActions
510(k) K252241 Pressio 3 Multi-parameter Neuromonitoring SystemGWM2026-04-10 View
510(k) K250636 Sophy Mini Monopressure Valve (SM1)JXG2025-11-28 View
510(k) K242974 External CSF Drainage Ventricular Catheters, External CSF Drainage Lumbar CathetersJXG2025-06-20 View
510(k) K222422 Polaris Valve Electronic Reading InstrumentJXG2023-02-02 View
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