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510(k) K250636

Sophy Mini Monopressure Valve (SM1) by Sophysa — Product Code JXG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 28, 2025
Date Received
March 3, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Shunt, Central Nervous System And Components
Device Class
Class II
Regulation Number
882.5550
Review Panel
NE
Submission Type

Other clearances by Sophysa

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  • K162108 — Pressio 2 ICP Monitoring System (April 17, 2017)
  • K141227 — POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM/POLARIS ADJUSTABLE VALVE WITH SIPHONX (April 2, 2015)
  • K091328 — SIPHONX GRAVITATIONAL ANTISIPHON DEVICE (January 22, 2010)
  • K090342 — POLARIS PRESSURE ADJUSTABLE VALVE, MODELS SPV, SPVA, SPVB, SPV-140, SPV-300, SPV (August 11, 2009)
  • K062584 — PRESSIO ICP MONITORING SYSTEM (July 5, 2007)
  • K042481 — POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM, MODELS SPV-140, SPV-300, SPV-400 (December 14, 2004)
  • K031097 — POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM MODES SPV, SPVA, SPVB (February 26, 2004)
  • K013488 — SOPHY PRESSURE ADJUSTABLE VALVE SYSTEM MODEL SM8 (March 27, 2002)

Other clearances for product code JXG

  • K251598 — Intellidrop (December 10, 2025)
  • K252514 — EVAC-MRI (November 5, 2025)
  • K243531 — Codman Libertís Shunt Catheter with Bactiseal and Endexo Technology (August 8, 2025)
  • K243552 — Codman Libertís™ 1.5 mm EVD Catheter with Bactiseal® and Endexo® Technology with (August 6, 2025)
  • K242974 — External CSF Drainage Ventricular Catheters, External CSF Drainage Lumbar Cathet (June 20, 2025)
  • K243205 — EVAC (June 3, 2025)
  • K243676 — Duet External Drainage and Monitoring System (EDMS) (March 10, 2025)
  • K242003 — XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter Set (December 16, 2024)
  • K241458 — Borvo EVAC System (Ergo); Borvo EVAC System (Classic) (August 20, 2024)
  • K233445 — Bactiseal Catheters; Bactiseal Barium Striped Catheters; Bactiseal Endoscopic Ve (January 17, 2024)