Flexiblade

FDA 510(k) K984101 · Arco Medic , Ltd.

Substantially Equivalent

510(k) numberK984101

Submission

Device name
Flexiblade
Applicant
Arco Medic , Ltd.
Ra'Ananna 43373, IL
Received
November 17, 1998
Decision date
September 3, 1999
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
CCW – Laryngoscope, Rigid
Device class
Class I (low risk)
Regulation
21 CFR 868.5540
Specialty
Anesthesiology

Other 510(k)s with product code CCW

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K191602APA Oxy BladeCCW · Traditional Venner Medical (Singapore) Pte, Ltd.08/02/2019SE
K163412Girgis Scope Video 200 Double Bladed Laryngoscope (GSV200.DBL)CCW · Traditional Girgis Scope, LLC06/22/2017SE
K140951Yeescope LaryngoscopesCCW · Traditional Yeescope Pty. , Ltd.11/10/2014SE
K121378Airtraq SP Airtraq AvantCCW · Traditional Prodol Meditec , Ltd.06/21/2012SE
K063477Novamed MRI Conditional Laryngoscope SetCCW · Traditional Novamed, LLC02/09/2007SE
K062523Tru-Mr Laryngoscope SetCCW · Traditional Truphatek International, Ltd.11/17/2006SE
K062231MR Fiber Optic Intubating Laryngoscope Handle, Standard, Model 310001CCW · Special Minrad, Inc.08/31/2006SE
K062230MR Fiber Optic Intubating Laryngoscope Handle, Short, Model 310002CCW · Special Minrad, Inc.08/31/2006SE
K041852MR Tested Fiber Optic Short Laryngoscope Handle, Model 310002CCW · Traditional Minrad, Inc.11/15/2004SE
K971377Greatbatch Scientific MR Compatible LaryngoscopeCCW · Traditional Wilson Greatbatch Technologies, Inc.04/30/1998SE

Questions and answers

When was Flexiblade cleared by the FDA?

Flexiblade (K984101) received a 510(k) decision of Substantially Equivalent on September 3, 1999, 290 days after the submission was received.

What is the product code of K984101?

The FDA product code is CCW – Laryngoscope, Rigid, a Class I (low risk) device regulated under 21 CFR 868.5540.