D.L. Scope Blade & Handle
FDA 510(k) K841778 · North American Medical Products, Inc.
510(k) numberK841778
Submission
- Device name
- D.L. Scope Blade & Handle
- Applicant
- North American Medical Products, Inc.
Walker, MI, US - Received
- April 30, 1984
- Decision date
- May 23, 1984
- 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
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 |
| 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 |
|---|---|---|
| K001965 | Safe-Point Vac, Safe-Point M-D Blood Collection SystemsFMI · Traditional | 02/02/2001SE |
| K905305 | Safe-Site Needle CoverFMI · Traditional | 02/12/1991SE |
| K895948 | Port-O-Scope(Tm)EOQ · Traditional | 03/27/1990SE |
| K896072 | D.L. Scope OphthalmoscopeHLJ · Traditional | 11/27/1989SE |
| K862661 | D.L. Scope(R) OtoscopeERA · Traditional | 08/08/1986SE |
Questions and answers
When was D.L. Scope Blade & Handle cleared by the FDA?
D.L. Scope Blade & Handle (K841778) received a 510(k) decision of Substantially Equivalent on May 23, 1984, 23 days after the submission was received.
What is the product code of K841778?
The FDA product code is CCW – Laryngoscope, Rigid, a Class I (low risk) device regulated under 21 CFR 868.5540.