| Device Type ID | 1448 |
| Device Name | Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece |
| Regulation Description | Ear, Nose, And Throat Electric Or Pneumatic Surgical Drill. |
| 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) |
| CFR Regulation Number | 874.4250 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | ERL |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
| Device Type ID | 1448 |
| Device | Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece |
| Product Code | ERL |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Ear, Nose, And Throat Electric Or Pneumatic Surgical Drill. |
| CFR Regulation Number | 874.4250 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
BIEN-AIR SURGERY SA | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ENTEROPTYX, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
GRACE MEDICAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
GYRUS ACMI, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
KARL STORZ GMBH & CO. KG | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
LAURIMED LLC | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
MEDTRONIC INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDTRONIC, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
STRYKER CORP. | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
STRYKER CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
THE ANSPACH EFFORT, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Overheating Of Device | 2479 |
Device Displays Incorrect Message | 432 |
Unintended System Motion | 311 |
Fail-Safe Problem | 267 |
Unintended Power Up | 250 |
Fluid Leak | 217 |
Output Below Specifications | 205 |
Noise, Audible | 156 |
Device Remains Activated | 152 |
Disassembly | 151 |
Leak / Splash | 136 |
Detachment Of Device Or Device Component | 106 |
Break | 82 |
Device Operates Differently Than Expected | 72 |
Bent | 65 |
Smoking | 65 |
Device Markings / Labelling Problem | 48 |
Device Inoperable | 43 |
Unintended Movement | 35 |
Material Fragmentation | 35 |
Air Leak | 31 |
Positioning Problem | 30 |
Hose | 30 |
Flaked | 24 |
Material Twisted / Bent | 23 |
Vibration | 19 |
Metal Shedding Debris | 18 |
Self-Activation Or Keying | 18 |
Mechanical Jam | 18 |
Electrical /Electronic Property Problem | 15 |
Material Rupture | 14 |
Cut In Material | 14 |
Unstable | 12 |
Mechanical Problem | 10 |
Hole In Material | 10 |
Motor | 10 |
Physical Resistance / Sticking | 9 |
Detachment Of Device Component | 9 |
Material Separation | 9 |
Difficult To Position | 9 |
Adverse Event Without Identified Device Or Use Problem | 9 |
Material Disintegration | 7 |
Fracture | 7 |
Loss Of Power | 7 |
Power Problem | 6 |
Sparking | 5 |
Unintended Ejection | 5 |
Loose Or Intermittent Connection | 5 |
Difficult To Insert | 4 |
Defective Device | 4 |
Unexpected Shutdown | 4 |
Bearings | 4 |
Component Missing | 4 |
Device Operational Issue | 4 |
Defective Component | 4 |
Material Integrity Problem | 3 |
Difficult To Remove | 3 |
Burst Container Or Vessel | 3 |
Use Of Device Problem | 3 |
Intermittent Continuity | 3 |
Connection Problem | 3 |
Hot Oil Leak | 3 |
Delivered As Unsterile Product | 3 |
Excessive Heating | 3 |
Fitting Problem | 3 |
Peeled / Delaminated | 3 |
Device Slipped | 3 |
Display Or Visual Feedback Problem | 3 |
Knife | 3 |
Crack | 2 |
Temperature Problem | 2 |
Component Falling | 2 |
Biocompatibility | 2 |
Decrease In Pressure | 2 |
Partial Blockage | 2 |
Device Contamination With Chemical Or Other Material | 2 |
Failure To Power Up | 2 |
Tube | 2 |
Device Dislodged Or Dislocated | 2 |
Infusion Or Flow Problem | 2 |
Contamination During Use | 2 |
Corroded | 2 |
Inappropriate Shock | 1 |
Device Stops Intermittently | 1 |
Pin | 1 |
Failure To Capture | 1 |
Handpiece | 1 |
Fail-Safe Did Not Operate | 1 |
Insulation | 1 |
Cutter | 1 |
No Flow | 1 |
Tip | 1 |
Appropriate Term/Code Not Available | 1 |
Intermittent Energy Output | 1 |
Structural Problem | 1 |
Delamination | 1 |
Degraded | 1 |
Material Puncture / Hole | 1 |
Seal | 1 |
Material Frayed | 1 |
| Total Device Problems | 5804 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Laurimed LLC | III | Apr-30-2014 |
| 2 | Stryker Instruments Div. Of Stryker Corporation | II | Mar-20-2014 |
| 3 | The Anspach Effort, Inc. | II | May-04-2017 |
| 4 | The Anspach Effort, Inc. | II | May-19-2016 |
| 5 | The Anspach Effort, Inc. | II | Jun-25-2014 |
| 6 | The Anspach Effort, Inc. | II | Jan-16-2014 |
| 7 | The Anspach Effort, Inc. | II | Jan-09-2014 |