Licox CMP MONITOR-AC3.1, Licox Imc Oxygen CATHETERS-CC1,CC1.SB Luicox Imc Introducer KITS-IM,IM2,IM3,II1 Licoximc Tempe
FDA 510(k) K002765 · Integra Neurosciences
510(k) numberK002765
Submission
- Device name
- Licox CMP MONITOR-AC3.1, Licox Imc Oxygen CATHETERS-CC1,CC1.SB Luicox Imc Introducer KITS-IM,IM2,IM3,II1 Licoximc Tempe
- Applicant
- Integra Neurosciences
San Diego, CA, US - Received
- September 5, 2000
- Decision date
- November 24, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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|---|---|---|---|
| K252241 | Pressio 3 Multi-parameter Neuromonitoring SystemGWM · Traditional | Sophysa | 04/10/2026SE |
| K250285 | Neurovent-P (092946-003); Neurovent (092956-003); Neurovent-Ifd-R (095317-003)…GWM · Traditional | Raumedic AG | 08/29/2025SE |
| K240821 | B4C System - Addition of new sensor model (BcSs-PICNIW-2000)GWM · Traditional | Braincare Desenvolvimento E Inovação Tecnológica… | 07/18/2024SE |
| K232890 | CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845)GWM · Traditional | Integra Lifesciences Production Corporation | 02/04/2024SE |
| K201989 | B4C SystemGWM · Traditional | Braincare Desenvolvimento E Inovacao Tecnologica… | 10/08/2021SE |
| K210993 | CereLink ICP MonitorGWM · Special | Integra Lifesciences Production Corporation | 04/30/2021SE |
| K201118 | Exacta External Drainage and Monitoring System, Exacta Pole with Laser Level, Exacta…GWM · Special | Medtronic, Inc. | 05/26/2020SE |
| K200630 | Medtronic External Drainage and Monitoring System, Medtronic External Drainage and…GWM · Special | Medtronic, Inc. | 04/09/2020SE |
| K200456 | Becker External Drainage and Monitoring SystemGWM · Special | Medtronic, Inc. | 03/26/2020SE |
| K182073 | BcSs-PICNI-2000 SensorGWM · Traditional | Braincare Desenvolvimento E Inovacao Tecnologica… | 10/17/2019SE |
More from Braincare Desenvolvimento E Inovacao Tecnologica S.A.
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| K082250 | Auragen Cortical Surface ElectrodesGYC · Special | 10/10/2008SE |
| K050720 | Neurosensor Cerebral Blood Flow and Intracranial Pressure Monitoring Kit/System, Models…GWM · Special | 05/11/2005SE |
| K042277 | Selector Quantum Ultrasonic Aspirator SystemLFL · Traditional | 09/29/2004SE |
| K031086 | Camino Single Parameter Monitor, Model SPM-1GWM · Special | 05/14/2003SE |
| K021989 | Selector Integra Ultrasonic Surgical Aspirator, Model Om 1530000M3LFL · Traditional | 09/13/2002SE |
| K022554 | Monitorr Icp External CSF Drainage and Monitoring SystemJXG · Special | 08/23/2002SE |
| K022553 | Camino Intracranial Pressure Monitoring Catheter with Licox Imc Bolt Fitting, Model 110-4LGWM · Special | 08/20/2002SE |
| K020558 | Licox CC1.G2 Brain Oxygen Catheter-MicroprobeGWM · Special | 03/21/2002SE |
Questions and answers
When was Licox CMP MONITOR-AC3.1, Licox Imc Oxygen CATHETERS-CC1,CC1.SB Luicox Imc Introducer KITS-IM,IM2,IM3,II1 Licoximc Tempe cleared by the FDA?
Licox CMP MONITOR-AC3.1, Licox Imc Oxygen CATHETERS-CC1,CC1.SB Luicox Imc Introducer KITS-IM,IM2,IM3,II1 Licoximc Tempe (K002765) received a 510(k) decision of Substantially Equivalent on November 24, 2000, 80 days after the submission was received.
What is the product code of K002765?
The FDA product code is GWM – Device, Monitoring, Intracranial Pressure, a Class II (moderate risk) device regulated under 21 CFR 882.1620.