| Device Type ID | 4595 |
| Device Name | Instrument, Cast Removal, Ac-powered |
| Regulation Description | Cast Removal Instrument. |
| Regulation Medical Specialty | Orthopedic |
| Review Panel | Orthopedic |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Orthopedic Devices (DOD) Joint And Fixation Devices Branch One ¿ Knees/Shoulders/Elbows/Ankles/Toes (JFDB1) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 888.5960 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | LGH |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4595 |
| Device | Instrument, Cast Removal, Ac-powered |
| Product Code | LGH |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Cast Removal Instrument. |
| CFR Regulation Number | 888.5960 [🔎] |
| Device Problems | |
|---|---|
Break | 3 |
Dull, Blunt | 2 |
Insufficient Information | 1 |
Excessive Heating | 1 |
Device Emits Odor | 1 |
Improper Or Incorrect Procedure Or Method | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
Smoking | 1 |
Failure To Cut | 1 |
| Total Device Problems | 12 |