LICOX IT2 COMPLETE BRAIN TUNNELING PROBE KIT
FDA 510(k) clearance K053244 · decided 2006-05-10
Clearance details
- K-number
- K053244
- Device name
- LICOX IT2 COMPLETE BRAIN TUNNELING PROBE KIT
- Applicant
- Integra Lifesciences Corp.
- Decision
- Substantially Equivalent
- Date received
- 2005-11-21
- Decision date
- 2006-05-10
- Days to decision
- 170 days
- Clearance type
- Special
- Product code
- GWM
- Device class
- 2
- Regulation number
- 882.1620
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Plainsboro, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Integra Licox Brain Tissue Oxygen Monitoring Integra Licox Recon Tissue Oxygen Monitoring recall (Z-0831-2015) | Integra LifeSciences Corp. | 2014-12-18 |