CCW · Laryngoscope, Rigid
Anesthesiology · 21 CFR 868.5540 · Class 1
Overview
| Product Code | CCW |
|---|---|
| Device Name | Laryngoscope, Rigid |
| Regulation | 21 CFR 868.5540 |
| Device Class | Class 1 |
| Review Panel | Anesthesiology |
Identification
A rigid laryngoscope is a device used to examine and visualize a patient's upper airway and aid placement of a tracheal tube.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9
Recent Cleared Devices (20 of 64)
Showing 20 most recent of 64 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K191602 | APA Oxy Blade | Venner Medical (Singapore) Pte, Ltd. | Aug 2, 2019 | SESE |
| K163412 | Girgis Scope Video 200 Double Bladed Laryngoscope (GSV200.DBL) | Girgis Scope, LLC | Jun 22, 2017 | SESE |
| K140951 | YEESCOPE LARYNGOSCOPES | Yeescope Pty. , Ltd. | Nov 10, 2014 | SESE |
| K121378 | AIRTRAQ SP AIRTRAQ AVANT | Prodol Meditec , Ltd. | Jun 21, 2012 | SESE |
| K063477 | NOVAMED MRI CONDITIONAL LARYNGOSCOPE SET | Novamed, LLC | Feb 9, 2007 | SESE |
| K062523 | TRU-MR LARYNGOSCOPE SET | Truphatek International, Ltd. | Nov 17, 2006 | SESE |
| K062231 | MR FIBER OPTIC INTUBATING LARYNGOSCOPE HANDLE, STANDARD, MODEL 310001 | Minrad, Inc. | Aug 31, 2006 | SESE |
| K062230 | MR FIBER OPTIC INTUBATING LARYNGOSCOPE HANDLE, SHORT, MODEL 310002 | Minrad, Inc. | Aug 31, 2006 | SESE |
| K041852 | MR TESTED FIBER OPTIC SHORT LARYNGOSCOPE HANDLE, MODEL 310002 | Minrad, Inc. | Nov 15, 2004 | SESE |
| K984101 | FLEXIBLADE | Arco Medic , Ltd. | Sep 3, 1999 | SESE |
| K971377 | GREATBATCH SCIENTIFIC MR COMPATIBLE LARYNGOSCOPE | Wilson Greatbatch Technologies, Inc. | Apr 30, 1998 | SESE |
| K970619 | GREATBATCH SCIENTIFIC MRI COMPATIBLE FIBER OPTIC LARYNGOSCOPE HANDLE | Wilson Greatbatch Technologies, Inc. | Nov 19, 1997 | SESE |
| K945590 | SCOPETEX(TM) | Smith Helms Mulliss & Moore, L.L.P. | May 20, 1997 | SESE |
| K961832 | BLUE RIDGE PRODUCTS LARYNGOSCOPE BLADE COVER | Blue Ridge Medical, Inc. | Sep 6, 1996 | SESE |
| K945301 | LARYNGOSCOPE COVER | Sotiria Mourkidou, M.D. | May 31, 1996 | SESE |
| K954787 | ILLUMINATOR | Hospitak, Inc. | Jan 31, 1996 | SESE |
| K954446 | AUGUSTINE INTUBATION GUIDE | Augustine Medical, Inc. | Dec 29, 1995 | SESE |
| K954438 | SUNMED'S GREENLINE FIBER OPTIC LARYNGOSCOPE | Rms Div. | Dec 29, 1995 | SESE |
| K953179 | CLM LARYNGOSCOPE | Penlon , Ltd. | Oct 6, 1995 | SESE |
| K951147 | LEIGH MED. TECH. LARYNGOSCOPE BLADE COVER | Leigh Med Tech, Inc. | Jun 8, 1995 | SESE |
Top Applicants
- Augustine Medical, Inc. — 5 clearances
- Eastmed Enterprises, Inc. — 5 clearances
- Minrad, Inc. — 3 clearances
- Michael S. Upsher — 2 clearances
- Wilson Greatbatch Technologies, Inc. — 2 clearances
