Optus Laryngoscopes
FDA 510(k) K945269 · Optus, Inc.
510(k) numberK945269
Submission
- Device name
- Optus Laryngoscopes
- Applicant
- Optus, Inc.
Denver, CO, US - Received
- October 28, 1994
- Decision date
- November 7, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- CCW – Laryngoscope, Rigid
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 868.5540
- Specialty
- Anesthesiology
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|---|---|---|---|
| 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 |
|---|---|---|
| K945264 | Optus OtoscopesERA · Traditional | 02/02/1996SE |
| K953913 | Optus Arthroscope & Mini-Arthroscope AccessoriesHRX · Traditional | 01/22/1996SE |
| K945268 | Optus BronchoscopesEOQ · Traditional | 12/21/1995SE |
| K945265 | Optus Hysteroscopes and Contact HysteroscopesHIH · Traditional | 09/12/1995SE |
| K945262 | Optus Cystoscopes and Pediatric CystoscopesFAJ · Traditional | 05/26/1995SE |
| K945267 | Optus Arthroscopes and Mini-ArthroscopesHRX · Traditional | 05/23/1995SE |
| K945266 | Optus Laparoscopes and Operating LaparoscopesGCJ · Traditional | 02/23/1995SE |
| K944656 | Optus Sinuscopes and AccessoriesEOB · Traditional | 01/26/1995SE |
| K945263 | Optus ThoracoscopesGCJ · Traditional | 12/13/1994SE |
Questions and answers
When was Optus Laryngoscopes cleared by the FDA?
Optus Laryngoscopes (K945269) received a 510(k) decision of Substantially Equivalent on November 7, 1994, 10 days after the submission was received.
What is the product code of K945269?
The FDA product code is CCW – Laryngoscope, Rigid, a Class I (low risk) device regulated under 21 CFR 868.5540.