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)— 510(k) K251499

Substantially Equivalent

William Cook Europe Aps

FDA 510(k) clearance K251499 for 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), Substantially Equivalent on 2025-06-11. Applicant: William Cook Europe Aps.

Clearance details

Applicant: William Cook Europe Aps
Product code: Code BTR
Advisory panel: Anesthesiology
Date received: 2025-05-15
Decision date: 2025-06-11
Decision: Substantially Equivalent
Clearance type: Special
Location: Bjaeverskov, DK

Download summary PDF View on FDA.gov ↗

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, 2020-01-01 through 2026-04-23. 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.