LICOX CC1.G2 BRAIN OXYGEN CATHETER-MICROPROBE— 510(k) K020558
Substantially EquivalentIntegra Neurosciences
FDA 510(k) clearance K020558 for LICOX CC1.G2 BRAIN OXYGEN CATHETER-MICROPROBE, Substantially Equivalent on 2002-03-21. Applicant: Integra Neurosciences. Device class: 2.
Clearance details
- Applicant
- Integra Neurosciences
- Product code
- Code GWM
- Device class
- Class 2
- Regulation
- 21 CFR 882.1620
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- San Diego, CA, US
Recent devices under product code GWM
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view all- K082250 — AURAGEN CORTICAL SURFACE ELECTRODES
- K050720 — NEUROSENSOR CEREBRAL BLOOD FLOW AND INTRACRANIAL PRESSURE MONITORING KIT/SYSTEM, MODELS NS-P, NS-100
- K031086 — CAMINO SINGLE PARAMETER MONITOR, MODEL SPM-1
- K021989 — SELECTOR INTEGRA ULTRASONIC SURGICAL ASPIRATOR, MODEL OM 1530000M3
- K022554 — MONITORR ICP EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM
Adverse events under product code GWM
product code GWM- Death
- 21
- Injury
- 732
- Malfunction
- 2,063
- Other
- 1
- Total
- 2,817
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.