| Device Type ID | 121 |
| Device Name | Laryngoscope, Rigid |
| Regulation Description | Rigid Laryngoscope. |
| Regulation Medical Specialty | Anesthesiology |
| Review Panel | Anesthesiology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) Anesthesiology Devices Branch (ANDB) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 868.5540 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | CCW |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 121 |
| Device | Laryngoscope, Rigid |
| Product Code | CCW |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Rigid Laryngoscope. |
| CFR Regulation Number | 868.5540 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
GIRGIS SCOPE LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
YEESCOPE PTY. LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
No Display / Image | 815 |
Erratic Or Intermittent Display | 300 |
Optical Problem | 254 |
Break | 222 |
Device Damaged Prior To Use | 145 |
Material Fragmentation | 51 |
Fitting Problem | 43 |
Device Markings / Labelling Problem | 41 |
Incorrect Device Or Component Shipped | 39 |
Device Operates Differently Than Expected | 35 |
Failure To Conduct | 31 |
Detachment Of Device Or Device Component | 27 |
Detachment Of Device Component | 26 |
Packaging Problem | 21 |
Appropriate Term/Code Not Available | 21 |
Overheating Of Device | 17 |
Battery Problem | 16 |
Connection Problem | 15 |
Inadequate Lighting | 14 |
Device Stops Intermittently | 14 |
Fracture | 13 |
Loose Or Intermittent Connection | 13 |
Difficult To Remove | 12 |
Difficult To Position | 11 |
Separation Failure | 9 |
Material Frayed | 9 |
Activation, Positioning Or Separation Problem | 8 |
Power Problem | 8 |
Material Separation | 8 |
Crack | 8 |
Temperature Problem | 8 |
Bent | 6 |
Light Interference | 6 |
Adverse Event Without Identified Device Or Use Problem | 6 |
Loss Of Or Failure To Bond | 5 |
Component Missing | 5 |
Mechanical Problem | 5 |
Disconnection | 5 |
Out-Of-Box Failure | 5 |
Mechanical Jam | 4 |
Material Integrity Problem | 4 |
Product Quality Problem | 3 |
Electrical /Electronic Property Problem | 3 |
Poor Quality Image | 3 |
Difficult To Insert | 3 |
Insufficient Information | 3 |
Other (for Use When An Appropriate Device Code Cannot Be Identified) | 2 |
Material Rupture | 2 |
Physical Resistance / Sticking | 2 |
Image Display Error / Artifact | 2 |
Device Handling Problem | 2 |
Material Protrusion / Extrusion | 2 |
Difficult Or Delayed Positioning | 2 |
Device Difficult To Setup Or Prepare | 2 |
Improper Device Output | 2 |
Device Inoperable | 2 |
Improper Or Incorrect Procedure Or Method | 2 |
Image Resolution Poor | 2 |
Corroded | 1 |
Charging Problem | 1 |
Defective Component | 1 |
Smoking | 1 |
Use Of Device Problem | 1 |
Metal Shedding Debris | 1 |
Structural Problem | 1 |
Degraded | 1 |
Device Dislodged Or Dislocated | 1 |
Material Split, Cut Or Torn | 1 |
Invalid Sensing | 1 |
Failure To Power Up | 1 |
Component Incompatible | 1 |
Unintended Movement | 1 |
Difficult Or Delayed Activation | 1 |
Difficult To Advance | 1 |
Positioning Problem | 1 |
Defective Device | 1 |
No Device Output | 1 |
Display Or Visual Feedback Problem | 1 |
Knife | 1 |
| Total Device Problems | 2365 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Aircraft Medical Limited | II | Dec-02-2014 |
| 2 | Bomimed | II | Sep-29-2017 |
| 3 | Teleflex Medical | II | Feb-23-2018 |
| 4 | Teleflex Medical | II | Jul-29-2014 |
| 5 | Teleflex Medical | II | Jul-26-2014 |
| 6 | Verathon Inc | II | Apr-18-2017 |
| 7 | Verathon, Inc. | I | Mar-11-2016 |
| 8 | Verathon, Inc. | II | Dec-15-2015 |
| 9 | Verathon, Inc. | II | Jul-13-2015 |