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510(k) K232890

CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845) by Integra Lifesciences Production Corporation — Product Code GWM

K232890 is an FDA 510(k) premarket notification submitted by Integra Lifesciences Production Corporation for the device "CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845)". The FDA issued a decision of Substantially Equivalent on February 4, 2024. The device falls under product code GWM (Device, Monitoring, Intracranial Pressure), a Class II device regulated under 21 CFR 882.1620. Integra Lifesciences Production Corporation has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 4, 2024
Date Received
September 18, 2023
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 Integra Lifesciences Production Corporation

  • K261004 — Codman® Distal Peritoneal Catheter, Barium Open End (82-1682); Codman® HOLTER® P (June 23, 2026)
  • 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)
  • K233445 — Bactiseal Catheters; Bactiseal Barium Striped Catheters; Bactiseal Endoscopic Ve (January 17, 2024)
  • K233448 — Bactiseal EVD Catheter Sets; Bactiseal Clear EVD Catheter Set (December 19, 2023)
  • K223330 — Certas Plus Programmable Valves (February 1, 2023)
  • K221840 — Hakim Programmable Valves, Hakim Precision Fixed Pressure Valves (October 14, 2022)
  • K210993 — CereLink ICP Monitor (April 30, 2021)

Other clearances for product code GWM

  • K252241 — Pressio 3 Multi-parameter Neuromonitoring System (April 10, 2026)
  • 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)
  • 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)

FDA data resources