Home / 510(k) Clearances / K042359

510(k) K042359

SUBDURAL EVACUATING PORT SYSTEM CRANIAL ACCESS KIT (SEPS-CA), (SEPS-CAL), (SEPS-CAND),MODELS 11-0401 CA, 11-0401-CAL by Medical Designs, LLC — Product Code JXG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 17, 2004
Date Received
August 31, 2004
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 Medical Designs, LLC

  • K182352 — SP-LINK™ System (November 21, 2018)
  • K181591 — Fixated Asfora BULLET CAGE® (FABC) (September 26, 2018)
  • K143688 — ASFORA ANTERIOR CERVICAL PLATE SYSTEM (July 1, 2015)
  • K112648 — ASFORA BULLET CAGE (March 13, 2012)
  • K090048 — ASFORA BULLET CAGE SYSTEM (August 14, 2009)
  • K002970 — SUBDURAL EVACUATING PORT SYSTEM, MODEL 11-9901 (December 12, 2000)

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)