LICOX IT2 COMPLETE BRAIN TUNNELING PROBE KIT— 510(k) K053244
Substantially EquivalentIntegra Lifesciences Corp.
FDA 510(k) clearance K053244 for LICOX IT2 COMPLETE BRAIN TUNNELING PROBE KIT, Substantially Equivalent on 2006-05-10. Applicant: Integra Lifesciences Corp.. Device class: 2.
Clearance details
- Applicant
- Integra Lifesciences Corp.
- 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
- Plainsboro, NJ, US
Recent devices under product code GWM
view allMore clearances from Integra Lifesciences Corp.
view allAdverse 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 →
Recalls naming K053244
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K053244.
Data sourced from openFDA. This site is unofficial and independent of the FDA.