CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845)— 510(k) K232890
Substantially EquivalentIntegra Lifesciences Production Corporation
FDA 510(k) clearance K232890 for CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845), Substantially Equivalent on 2024-02-04. Applicant: Integra Lifesciences Production Corporation.
Clearance details
- Applicant
- Integra Lifesciences Production Corporation
- Product code
- Code GWM
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mansfield, MA, US
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.