Cleared Special

K062230 - MR FIBER OPTIC INTUBATING LARYNGOSCOPE HANDLE, SHORT, MODEL 310002
(FDA 510(k) Clearance)

K062230 · Minrad, Inc. · Anesthesiology
Aug 2006
Decision
29d
Days
Class 1
Risk

K062230 is an FDA 510(k) clearance for the MR FIBER OPTIC INTUBATING LARYNGOSCOPE HANDLE, SHORT, MODEL 310002, a Laryngoscope, Rigid (Class I — General Controls, product code CCW), submitted by Minrad, Inc. (Buffalo, US). The FDA issued a Cleared decision on August 31, 2006, 29 days after receiving the submission on August 2, 2006. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5540.

Submission Details

510(k) Number K062230 FDA.gov
FDA Decision Cleared SESE
Date Received August 02, 2006
Decision Date August 31, 2006
Days to Decision 29 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code CCW — Laryngoscope, Rigid
Device Class Class I — General Controls
CFR Regulation 21 CFR 868.5540

Similar Devices — CCW Laryngoscope, Rigid

All 63
APA Oxy Blade
K191602 · Venner Medical (Singapore) Pte, Ltd. · Aug 2019
Girgis Scope Video 200 Double Bladed Laryngoscope (GSV200.DBL)
K163412 · Girgis Scope, LLC · Jun 2017
YEESCOPE LARYNGOSCOPES
K140951 · Yeescope Pty. , Ltd. · Nov 2014
AIRTRAQ SP AIRTRAQ AVANT
K121378 · Prodol Meditec , Ltd. · Jun 2012
NOVAMED MRI CONDITIONAL LARYNGOSCOPE SET
K063477 · Novamed, LLC · Feb 2007
TRU-MR LARYNGOSCOPE SET
K062523 · Truphatek International, Ltd. · Nov 2006