Definition: ENT Microdebrider Is An Accessory To An ENT Drill System. It Is Intended To Remove Soft And Hard Tissue During Ear, Nost And Throat Surgery. These Devices Operate At High Speed For Precise Tissue Resection. (this Is For Reprocessed Sing Use ENT Micro
| Device Type ID | 1620 |
| Device Name | Microdebrider, Ent, High Speed, Single Use, Reprocessed |
| 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) |
| CFR Regulation Number | 874.4140 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | NLY |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1620 |
| Device | Microdebrider, Ent, High Speed, Single Use, Reprocessed |
| Product Code | NLY |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Ear, Nose, And Throat Bur. |
| CFR Regulation Number | 874.4140 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
MEDLINE RENEWAL | ||
SUBSTANTIALLY EQUIVALENT | 1 | |