Home / 510(k) Clearances / K920156

510(k) K920156

CLINICAL NEURO SYST MONITORR EXT CSF DRAIN/MONI SY by Clinical Neuro Systems, LLC — Product Code JXG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 16, 1992
Date Received
January 14, 1992
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 Clinical Neuro Systems, LLC

  • K961113 — CNS INTERCHANGEABLE BIT CRANIAL DRILL (June 5, 1996)
  • K930229 — CLINICAL NEURO SYSTEMS CRANIAL DRILL (March 16, 1993)
  • K922936 — CLINICAL NEURO SYSTEMS MONITORR ICP LUMBAR CATHETE (August 26, 1992)
  • K922941 — CLINICAL NEURO SYSTEMS MONITORR ICP VENTRICULAR CA (August 26, 1992)

Other clearances for product code JXG

  • K251598 — Intellidrop (December 10, 2025)
  • K250636 — Sophy Mini Monopressure Valve (SM1) (November 28, 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)