CereLink ICP Monitor, CereLink ICP Extension Cable— 510(k) K183406
Substantially EquivalentIntegra Lifesciences Corp.
FDA 510(k) clearance K183406 for CereLink ICP Monitor, CereLink ICP Extension Cable, Substantially Equivalent on 2019-01-11. 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
- Mansfield, MA, US
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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 →
Recalls naming K183406
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 K183406.
Data sourced from openFDA. This site is unofficial and independent of the FDA.