FXE · Speculum, Non-Illuminated
General, Plastic Surgery · 21 CFR 878.1800 · Class 1
Overview
| Product Code | FXE |
|---|---|
| Device Name | Speculum, Non-Illuminated |
| Regulation | 21 CFR 878.1800 |
| Device Class | Class 1 |
| Review Panel | General, Plastic Surgery |
Identification
A speculum is a device intended to be inserted into a body cavity to aid observation. It is either nonilluminated or illuminated and may have various accessories.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.
Recent Cleared Devices (0 of 0)
No cleared devices on record.
