Licox CC1.G2 Brain Oxygen Catheter-Microprobe
510(k) K020558
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK020558 | Date21 Mar 2002 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- GWM
- Device Class
- Class II
- Regulation
- 21 CFR Part 882.1620
- Advisory Committee
- Neurology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Licox CC1.G2 Brain Oxygen Catheter-Microprobe is a medical device classified as a monitoring probe for intracranial pressure and brain oxygenation. It measures partial pressure of oxygen (pO₂) in brain tissue, providing real-time data to assess cerebral oxygenation levels, which is critical in managing conditions such as traumatic brain injury, stroke, or intracranial hypertension. The device is designed for insertion into brain tissue to deliver precise oxygen measurements, aiding in clinical decision-making and patient outcomes.
The Licox CC1.G2 is intended for single-use and is supplied sterile, requiring no additional preparation beyond standard sterile surgical procedures. It is compatible for use in MRI environments, though specific safety guidelines must be followed. The device is regulated under FDA 510(k) clearance (K020558) and falls under product code GWM, adhering to regulatory standards for Class II medical devices. Storage and handling follow standard sterile medical device protocols to ensure functionality and safety prior to use.
Other devices from Integra Neurosciences
Questions
AI-generated answers, 1 Oct 2026
What is the Licox CC1.G2 Brain Oxygen Catheter-Microprobe used for?
The Licox CC1.G2 Brain Oxygen Catheter-Microprobe is designed to measure the partial pressure of oxygen (pO₂) in brain tissue, providing real-time data on cerebral oxygenation. This is essential for managing conditions such as traumatic brain injury, stroke, or intracranial hypertension, helping clinicians make informed decisions to improve patient outcomes.
Is the Licox CC1.G2 Brain Oxygen Catheter-Microprobe intended for single-use or reuse?
The Licox CC1.G2 Brain Oxygen Catheter-Microprobe is intended for single-use only. This design ensures patient safety and sterility, as it is supplied sterile and requires no additional preparation beyond standard sterile surgical procedures.
How is the Licox CC1.G2 Brain Oxygen Catheter-Microprobe supplied and prepared for use?
The device is supplied sterile and ready for immediate use after standard sterile surgical preparation. No additional sterilization or preparation steps are required beyond adhering to routine sterile medical device protocols.
Can the Licox CC1.G2 Brain Oxygen Catheter-Microprobe be used in MRI environments?
Yes, the Licox CC1.G2 is compatible for use in MRI environments, but specific safety guidelines must be followed to ensure proper operation and patient safety during imaging.
What regulatory approval does the Licox CC1.G2 Brain Oxygen Catheter-Microprobe hold?
The Licox CC1.G2 Brain Oxygen Catheter-Microprobe is regulated under FDA 510(k) clearance (K020558) and is classified as a Class II medical device under product code GWM. This clearance indicates it is deemed substantially equivalent to a legally marketed device.