| Device Type ID | 5653 |
| Device Name | Motor, Surgical Instrument, Pneumatic Powered |
| Regulation Description | Surgical Instrument Motors And Accessories/attachments. |
| Regulation Medical Specialty | General & Plastic Surgery |
| Review Panel | General & Plastic Surgery |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Surgical Devices (DSD) General Surgery Devices Branch One - Light Based/Laser (GSDB1) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 878.4820 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | GET |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5653 |
| Device | Motor, Surgical Instrument, Pneumatic Powered |
| Product Code | GET |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Surgical Instrument Motors And Accessories/attachments. |
| CFR Regulation Number | 878.4820 [🔎] |
| Device Problems | |
|---|---|
Failure To Align | 47 |
Break | 39 |
Difficult To Open Or Close | 24 |
Burst Container Or Vessel | 14 |
Detachment Of Device Component | 7 |
Mechanical Problem | 6 |
Product Quality Problem | 5 |
Material Split, Cut Or Torn | 3 |
Detachment Of Device Or Device Component | 3 |
Torn Material | 3 |
Mechanics Altered | 3 |
Entrapment Of Device | 2 |
Device Subassembly | 2 |
Tip | 2 |
Material Integrity Problem | 2 |
Inflation Problem | 2 |
Physical Resistance | 1 |
Fracture | 1 |
Bent | 1 |
Melted | 1 |
Material Puncture / Hole | 1 |
Failure To Cut | 1 |
Peeled / Delaminated | 1 |
Material Separation | 1 |
Material Protrusion / Extrusion | 1 |
Positioning Problem | 1 |
Noise, Audible | 1 |
Overheating Of Device | 1 |
Defective Device | 1 |
| Total Device Problems | 177 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Aesculap, Inc. | II | Jan-03-2014 |
| 2 | MicroAire Surgical Instruments, LLC | II | May-27-2016 |
| 3 | The Anspach Effort, Inc. | II | May-04-2017 |