| Device Type ID | 5497 |
| Device Name | Speculum, Ent |
| Regulation Description | Speculum And Accessories. |
| Regulation Medical Specialty | General & Plastic Surgery |
| Review Panel | General & Plastic Surgery |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Surgical Devices (DSD) Plastic And Reconstructive Surgery Devices Branch One - Implants And Tools (PRSB1) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 878.1800 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | EPY |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5497 |
| Device | Speculum, Ent |
| Product Code | EPY |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Speculum And Accessories. |
| CFR Regulation Number | 878.1800 [🔎] |
| Device Problems | |
|---|---|
Patient-Device Incompatibility | 4 |
Difficult To Open Or Close | 4 |
Break | 1 |
| Total Device Problems | 9 |