APA Oxy Blade
FDA 510(k) K191602 · Venner Medical (Singapore) Pte, Ltd.
510(k) numberK191602
Submission
- Device name
- APA Oxy Blade
- Applicant
- Venner Medical (Singapore) Pte, Ltd.
Singapore, SG - Received
- June 17, 2019
- Decision date
- August 2, 2019
- 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 |
|---|---|---|---|
| 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 |
| K971377 | Greatbatch Scientific MR Compatible LaryngoscopeCCW · Traditional | Wilson Greatbatch Technologies, Inc. | 04/30/1998SE |
More from Wilson Greatbatch Technologies, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K192511 | Venner PneuX TT (Tracheostomy Tube) Size 7.0 mm, Venner PneuX TT (Tracheostomy Tube)…BTO · Traditional | 07/22/2020SE |
| K192120 | Venner PneuX ETT (Endotracheal Tube) 6 mm, Venner PneuX ETT (Endotracheal Tube) 7 mm…BTR · Traditional | 02/14/2020SE |
| K110631 | Venner Tracheal Seal MonitorBSK · Traditional | 07/28/2011SE |
| K100950 | Venner Pneux P.Y. (TM) Tracheostomy TubeBTO · Traditional | 07/13/2010SE |
| K093135 | Venner Pneux P.Y. (TM) Tracheostomy Tube and Endo Tracheal TubeBTR · Traditional | 04/02/2010SE |
Questions and answers
When was APA Oxy Blade cleared by the FDA?
APA Oxy Blade (K191602) received a 510(k) decision of Substantially Equivalent on August 2, 2019, 46 days after the submission was received.
What is the product code of K191602?
The FDA product code is CCW – Laryngoscope, Rigid, a Class I (low risk) device regulated under 21 CFR 868.5540.