Home / 510(k) Clearances / K152670

510(k) K152670

DirectLink ICP Module, DirectLink ICP Extension Cable, Patient Monitor Interface Cables by Medos International SARL — Product Code GWM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 22, 2016
Date Received
September 17, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Monitoring, Intracranial Pressure
Device Class
Class II
Regulation Number
882.1620
Review Panel
NE
Submission Type

Other clearances by Medos International SARL

  • K253249 — TriALTIS™ Spine System (October 21, 2025)
  • K243249 — TriALTIS™ Spine System (January 17, 2025)
  • K241893 — CROSSNAV Navigation Enabled Instruments and UNAS Navigation Arrays (September 16, 2024)
  • K242042 — TriALTIS™ Spine System (September 9, 2024)
  • K233684 — TriALTIS™ Spine System (December 12, 2023)
  • K233366 — SYMPHONY OCT System (November 9, 2023)
  • K232492 — 2.7 mm GRYPHON™ Flex Knotless PEEK Anchor; 2.7 mm GRYPHON™ Flex Knotless Biocomp (October 6, 2023)
  • K231479 — TriALTIS Spine System (September 22, 2023)
  • K223438 — TELIGEN System Peripheral Motor Nerve Stimulation Indications (February 10, 2023)
  • K223108 — TELIGEN System Navigation Ready Indications (TELIGEN Access Probe, TELIGEN Clear (January 19, 2023)

Other clearances for product code GWM

  • K250285 — NEUROVENT-P (092946-003); NEUROVENT (092956-003); NEUROVENT-IFD-R (095317-003); (August 29, 2025)
  • K240821 — B4C System - Addition of new sensor model (BcSs-PICNIW-2000) (July 18, 2024)
  • K232890 — CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845) (February 4, 2024)
  • K201989 — B4C System (October 8, 2021)
  • K210993 — CereLink ICP Monitor (April 30, 2021)
  • K201118 — Exacta External Drainage and Monitoring System, Exacta Pole with Laser Level, Ex (May 26, 2020)
  • K200630 — Medtronic External Drainage and Monitoring System, Medtronic External Drainage a (April 9, 2020)
  • K200456 — Becker External Drainage and Monitoring System (March 26, 2020)
  • K182073 — BcSs-PICNI-2000 Sensor (October 17, 2019)
  • K183406 — CereLink ICP Monitor, CereLink ICP Extension Cable (January 11, 2019)