Frova Intubating Introducer (4 models)— 510(k) K251499
Substantially EquivalentWilliam Cook Europe Aps
FDA 510(k) clearance K251499 for Frova Intubating Introducer (4 models), Substantially Equivalent on 2025-06-11. Applicant: William Cook Europe Aps. Device class: 2.
Clearance details
- Device name as filed
- Frova Intubating Introducer (C-CAE-14.0-70-FII); Frova Intubating Introducer (C-CAE-14.0-70-FI); Frova Intubating Introducer (C-CAE-14.0-70-FIC); Frova Intubating Introducer (C-CAE-14.0-70-FIC-SPOPS)
- Applicant
- William Cook Europe Aps
- Product code
- Code BTR
- Device class
- Class 2
- Regulation
- 21 CFR 868.5730
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Bjaeverskov, DK
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Adverse events under product code BTR
product code BTR- Death
- 92
- Injury
- 1,263
- Malfunction
- 7,475
- Other
- 2
- Total
- 8,832
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.