MR Fiber Optic Intubating Laryngoscope Handle, Short, Model 310002
FDA 510(k) K062230 · Minrad, Inc.
510(k) numberK062230
Submission
- Device name
- MR Fiber Optic Intubating Laryngoscope Handle, Short, Model 310002
- Applicant
- Minrad, Inc.
Buffalo, NY, US - Received
- August 2, 2006
- Decision date
- August 31, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CCW – Laryngoscope, Rigid
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 868.5540
- Specialty
- Anesthesiology
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| K163412 | Girgis Scope Video 200 Double Bladed Laryngoscope (GSV200.DBL)CCW · Traditional | Girgis Scope, LLC | 06/22/2017SE |
| K140951 | Yeescope LaryngoscopesCCW · Traditional | Yeescope Pty. , Ltd. | 11/10/2014SE |
| K121378 | Airtraq SP Airtraq AvantCCW · Traditional | Prodol Meditec , Ltd. | 06/21/2012SE |
| K063477 | Novamed MRI Conditional Laryngoscope SetCCW · Traditional | Novamed, LLC | 02/09/2007SE |
| K062523 | Tru-Mr Laryngoscope SetCCW · Traditional | Truphatek International, Ltd. | 11/17/2006SE |
| K062231 | MR Fiber Optic Intubating Laryngoscope Handle, Standard, Model 310001CCW · Special | Minrad, Inc. | 08/31/2006SE |
| K041852 | MR Tested Fiber Optic Short Laryngoscope Handle, Model 310002CCW · Traditional | Minrad, Inc. | 11/15/2004SE |
| K984101 | FlexibladeCCW · Traditional | Arco Medic , Ltd. | 09/03/1999SE |
| K971377 | Greatbatch Scientific MR Compatible LaryngoscopeCCW · Traditional | Wilson Greatbatch Technologies, Inc. | 04/30/1998SE |
More from Wilson Greatbatch Technologies, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K072255 | Minrad Inc. Nasal Scavenging CircuitCBN · Traditional | 10/18/2007SE |
| K071814 | Light Sabre Spinal Access DeviceKNW · Traditional | 10/16/2007SE |
| K062231 | MR Fiber Optic Intubating Laryngoscope Handle, Standard, Model 310001CCW · Special | 08/31/2006SE |
| K041852 | MR Tested Fiber Optic Short Laryngoscope Handle, Model 310002CCW · Traditional | 11/15/2004SE |
| K041846 | Sabresource DrapeKKX · Traditional | 08/26/2004SE |
| K021084 | Light Saber Spinal NeedleFMF · Traditional | 07/03/2002SE |
| K013040 | Light Saber Introducer NeedleMDM · Traditional | 12/07/2001SE |
| K982735 | Light Saber Bone Biopsy NeedleKNW · Traditional | 09/09/1998SE |
| K982018 | Light Saber Aspiration NeedleFMF · Traditional | 08/07/1998SE |
| K981796 | Light Saber Core Tissue NeedleKNW · Traditional | 08/05/1998SE |
Questions and answers
When was MR Fiber Optic Intubating Laryngoscope Handle, Short, Model 310002 cleared by the FDA?
MR Fiber Optic Intubating Laryngoscope Handle, Short, Model 310002 (K062230) received a 510(k) decision of Substantially Equivalent on August 31, 2006, 29 days after the submission was received.
What is the product code of K062230?
The FDA product code is CCW – Laryngoscope, Rigid, a Class I (low risk) device regulated under 21 CFR 868.5540.