Augustine Guide Kit
FDA 510(k) K921166 · Augustine Medical, Inc.
510(k) numberK921166
Submission
- Device name
- Augustine Guide Kit
- Applicant
- Augustine Medical, Inc.
Eden Prairie, MN, US - Received
- March 11, 1992
- Decision date
- April 23, 1992
- 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
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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 |
|---|---|---|
| K021473 | Bair Hugger Temperature Management SystemDWJ · Traditional | 07/09/2002SE |
| K020077 | Modification to Augustine Medical Wound Care System, Model 68XXXMSA · Special | 01/31/2002SE |
| K001149 | Augustine Medical Bair Huuger, Model 750 Total Temperature Management System-(Model 750…DWJ · Traditional | 09/06/2000SE |
| K973741 | Bair Hugger Blood/Fluid WarmerBSB · Traditional | 04/30/1998SE |
| K964673 | Bair Hugger Model 630 Cardiac BlanketDWJ · Traditional | 06/26/1997SE |
| K963293 | Augustine Medical Wound Care System Model 68XXXMSA · Traditional | 03/28/1997SN |
| K963672 | Model 90022 Rolling StandJOW · Traditional | 01/06/1997SE |
| K960167 | System, Thermal Regulating 74-DWJDWJ · Traditional | 06/17/1996SE |
| K954446 | Augustine Intubation GuideCCW · Traditional | 12/29/1995SE |
| K952864 | Bair Hugger Model 655 BlanketDWJ · Traditional | 09/12/1995SE |
Questions and answers
When was Augustine Guide Kit cleared by the FDA?
Augustine Guide Kit (K921166) received a 510(k) decision of Substantially Equivalent on April 23, 1992, 43 days after the submission was received.
What is the product code of K921166?
The FDA product code is CCW – Laryngoscope, Rigid, a Class I (low risk) device regulated under 21 CFR 868.5540.