Home / 510(k) Clearances / K131184

510(k) K131184

INTEGRA LICOX PTO2 MONITOR by Integra Lifesciences Corp. — Product Code GWM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 30, 2013
Date Received
April 25, 2013
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 Corp.

  • K183581 — Codman Disposable Perforators (January 20, 2019)
  • K183406 — CereLink ICP Monitor, CereLink ICP Extension Cable (January 11, 2019)
  • K182265 — CodMan Certas Plus Programmable Valve (November 20, 2018)
  • K181902 — Codman Certas Plus Electronic Tool Kit (October 25, 2018)
  • K150682 — CUSA Excel+ (December 18, 2015)
  • K150428 — Integra (R) Jarit (R) Kerrison Rongeurs, Integra (R) Ruggles (TM)-Redmons (TM) K (April 16, 2015)
  • K092227 — JARIT, RUGGLES, R&B REDMOND/ REDMOND, MILTEX, MEISTERHAND - KERRISON RONGEURS (February 17, 2010)
  • K092395 — OSV II LUMBAR VALVE SYSTEM AND OSV II LOW FLOW LUMBAR VALVE SYSTEM (November 19, 2009)
  • K081635 — INTEGRA MESHED BILAYER WOUND MATRIX (December 4, 2008)
  • K081401 — MAYFIELD MR/X-RAY SKULL CLAMP (October 8, 2008)

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)