Laryngostat Laryngoscope Handle
FDA 510(k) K895954 · Michigan Instruments, Inc.
510(k) numberK895954
Submission
- Device name
- Laryngostat Laryngoscope Handle
- Applicant
- Michigan Instruments, Inc.
Grand Rapids, MI, US - Received
- October 11, 1989
- Decision date
- October 30, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| K062230 | MR Fiber Optic Intubating Laryngoscope Handle, Short, Model 310002CCW · 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 |
More from Arco Medic , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K073079 | Thumper, Model: 1008DRM · Traditional | 02/14/2008SE |
| K972525 | ThumperDRM · Traditional | 10/02/1997SE |
| K962237 | Thumper Cardiopulmonary ResuscitatorDRM · Traditional | 09/05/1996SE |
| K851139 | Thumper Cardiopulmonary Resuscitator 1005DRM · Traditional | 05/15/1985SE |
| K833879 | Cardiopulmonary ResuscitatorDRM · Traditional | 12/27/1983SE |
| K811909 | Cardiopulmunary ResuscitatorDRM · Traditional | 07/16/1981SE |
Questions and answers
When was Laryngostat Laryngoscope Handle cleared by the FDA?
Laryngostat Laryngoscope Handle (K895954) received a 510(k) decision of Substantially Equivalent on October 30, 1989, 19 days after the submission was received.
What is the product code of K895954?
The FDA product code is CCW – Laryngoscope, Rigid, a Class I (low risk) device regulated under 21 CFR 868.5540.