| Device Type ID | 1444 |
| Device Name | Bur, Ear, Nose And Throat |
| Regulation Description | Ear, Nose, And Throat Bur. |
| Regulation Medical Specialty | Ear Nose & Throat |
| Review Panel | Ear Nose & Throat |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Ophthalmic And Ear, Nose And Throat Devices (DOED) Ear, Nose, And Throat Devices Branch (ENTB) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 874.4140 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | EQJ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1444 |
| Device | Bur, Ear, Nose And Throat |
| Product Code | EQJ |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Ear, Nose, And Throat Bur. |
| CFR Regulation Number | 874.4140 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
STRYKER CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
STRYKER CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Break | 188 |
Material Fragmentation | 130 |
Material Separation | 79 |
Overheating Of Device | 24 |
Vibration | 11 |
Use Of Device Problem | 10 |
Adverse Event Without Identified Device Or Use Problem | 8 |
Contamination / Decontamination Problem | 5 |
Unintended System Motion | 5 |
Inability To Irrigate | 5 |
Stretched | 4 |
Mechanical Jam | 3 |
Obstruction Of Flow | 3 |
Tip | 3 |
Fracture | 3 |
Detachment Of Device Component | 2 |
Physical Resistance / Sticking | 2 |
Leak / Splash | 1 |
Fitting Problem | 1 |
Off-Label Use | 1 |
Complete Blockage | 1 |
Packaging Problem | 1 |
Knife | 1 |
Noise, Audible | 1 |
Display Or Visual Feedback Problem | 1 |
Thermal Decomposition Of Device | 1 |
Flaked | 1 |
Device Operates Differently Than Expected | 1 |
Unstable | 1 |
Failure To Cut | 1 |
Device Dislodged Or Dislocated | 1 |
Metal Shedding Debris | 1 |
Self-Activation Or Keying | 1 |
| Total Device Problems | 501 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Gyrus ACMI, Inc. | II | Mar-20-2018 |