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510(k) K881183

VENTRICULAR BOLT PRESSURE MONITORING KIT #110-4H by Camino Laboratories, Inc. — Product Code GWM

K881183 is an FDA 510(k) premarket notification submitted by Camino Laboratories, Inc. for the device "VENTRICULAR BOLT PRESSURE MONITORING KIT #110-4H". The FDA issued a decision of Substantially Equivalent on May 4, 1988. The device falls under product code GWM (Device, Monitoring, Intracranial Pressure), a Class II device regulated under 21 CFR 882.1620. Camino Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 4, 1988
Date Received
March 21, 1988
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 Camino Laboratories, Inc.

  • K932769 — CAMINO VENTRICULAR DRAINAGE SYSTEM (March 30, 1995)
  • K930222 — CAMINO VENTRICULAR ACCESS DEVICE (April 15, 1993)
  • K930221 — CAMINO VENTRICULAR TRANSDUCER ACCESSORY (April 15, 1993)
  • K920088 — CAMINO VENTRICULAR NEEDLE (May 1, 1992)
  • K914735 — VENTRICULAR PRESSURE MONITORING KIT, MODEL 110-4HM (January 17, 1992)
  • K912833 — CAMINO MODEL M420: MONIT INTER W/MEAN PRES DISPLAY (September 23, 1991)
  • K893232 — MODEL V420 DIRECT PRESSURE MONITOR & 427 WAVEFORM (July 14, 1989)
  • K863969 — CAMINO COMPARTMENTAL PRESS MONITOR CATH/110-4D (May 27, 1987)
  • K861961 — CAMINO CSF DRAINAGE SYSTEM MODEL 040 (August 12, 1986)
  • K862160 — CAMINO HAND DRILL - MODEL 030 (July 18, 1986)

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)
  • 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)

FDA data resources