Tru-Mr Laryngoscope Set
FDA 510(k) K062523 · Truphatek International, Ltd.
510(k) numberK062523
Submission
- Device name
- Tru-Mr Laryngoscope Set
- Applicant
- Truphatek International, Ltd.
Bonita Springs, FL, US - Received
- August 28, 2006
- Decision date
- November 17, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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
Other 510(k)s with product code CCW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K191602 | APA Oxy BladeCCW · Traditional | Venner Medical (Singapore) Pte, Ltd. | 08/02/2019SE |
| 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 |
| 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 |
| K971377 | Greatbatch Scientific MR Compatible LaryngoscopeCCW · Traditional | Wilson Greatbatch Technologies, Inc. | 04/30/1998SE |
More from Wilson Greatbatch Technologies, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K063309 | Tru-CableFFS · Traditional | 01/12/2007SE |
Questions and answers
When was Tru-Mr Laryngoscope Set cleared by the FDA?
Tru-Mr Laryngoscope Set (K062523) received a 510(k) decision of Substantially Equivalent on November 17, 2006, 81 days after the submission was received.
What is the product code of K062523?
The FDA product code is CCW – Laryngoscope, Rigid, a Class I (low risk) device regulated under 21 CFR 868.5540.