Greatbatch Scientific MRI Compatible Fiber Optic Laryngoscope Handle
FDA 510(k) K970619 · Wilson Greatbatch Technologies, Inc.
510(k) numberK970619
Submission
- Device name
- Greatbatch Scientific MRI Compatible Fiber Optic Laryngoscope Handle
- Applicant
- Wilson Greatbatch Technologies, Inc.
Clarence, NY, US - Received
- February 18, 1997
- Decision date
- November 19, 1997
- 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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| 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 |
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| 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 |
|---|---|---|
| K971374 | Greatbatch Scientific MR Compatible HysteroscopeHIH · Traditional | 05/13/1998SE |
| K971377 | Greatbatch Scientific MR Compatible LaryngoscopeCCW · Traditional | 04/30/1998SE |
| K972280 | Greatbatch Scientific MR Compatible Laparoscopes and Operating LaparoscopesGCJ · Traditional | 12/11/1997SE |
| K971781 | Greatbatch Scientific MR Compatible Arthroscopes and Small Joint ArthroscopesHRX · Traditional | 11/21/1997SE |
| K971375 | Greatbatch Scientific MR Compatible SinuscopeEOB · Traditional | 10/31/1997SE |
| K954649 | WGL Endoscopic Grasper W/Detachable StrapGCJ · Traditional | 12/22/1995SE |
| K950063 | WGL Endoscopic Grasper*GCJ · Traditional | 01/27/1995SE |
| K942168 | WGL Endoscopic GrasperGCJ · Traditional | 12/13/1994SE |
Questions and answers
When was Greatbatch Scientific MRI Compatible Fiber Optic Laryngoscope Handle cleared by the FDA?
Greatbatch Scientific MRI Compatible Fiber Optic Laryngoscope Handle (K970619) received a 510(k) decision of Substantially Equivalent on November 19, 1997, 274 days after the submission was received.
What is the product code of K970619?
The FDA product code is CCW – Laryngoscope, Rigid, a Class I (low risk) device regulated under 21 CFR 868.5540.