Cleared Special

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)

K251499 · William Cook Europe Aps · Anesthesiology
Jun 2025
Decision
27d
Days
Class 2
Risk

About This 510(k) Submission

K251499 is an FDA 510(k) clearance for the 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), a Tube, Tracheal (w/wo Connector) (Class II — Special Controls, product code BTR), submitted by William Cook Europe Aps (Bjaeverskov, DK). The FDA issued a Cleared decision on June 11, 2025, 27 days after receiving the submission on May 15, 2025. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5730.

Submission Details

510(k) Number K251499 FDA.gov
FDA Decision Cleared SESE
Date Received May 15, 2025
Decision Date June 11, 2025
Days to Decision 27 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BTR — Tube, Tracheal (w/wo Connector)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5730

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