Laryngescope
FDA 510(k) K831981 · W.E. Leder Enterprises, Inc.
510(k) numberK831981
Submission
- Device name
- Laryngescope
- Applicant
- W.E. Leder Enterprises, Inc.
Mchenry, IL, US - Received
- June 20, 1983
- Decision date
- September 29, 1983
- 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 |
|---|---|---|
| K831877 | Arf 850 ECBK · Traditional | 11/03/1983SE |
| K831878 | Cardio-Scope Mini MonitorDPS · Traditional | 09/29/1983SE |
| K830161 | Anesthesia Apatatus #D-25BSZ · Traditional | 03/09/1983SE |
| K830160 | Anesthesia Apparatus #Fo 20SBSZ · Traditional | 03/09/1983SE |
| K830159 | Anesthesia Apparatus PH-35BSZ · Traditional | 03/09/1983SE |
Questions and answers
When was Laryngescope cleared by the FDA?
Laryngescope (K831981) received a 510(k) decision of Substantially Equivalent on September 29, 1983, 101 days after the submission was received.
What is the product code of K831981?
The FDA product code is CCW – Laryngoscope, Rigid, a Class I (low risk) device regulated under 21 CFR 868.5540.