21 CFR 878.1800 — Speculum, Ent
General, Plastic Surgery (SU) · Part 878 Subpart B—Diagnostic Devices · § 878.1800
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| EPY | Speculum, Ent | 1 | 12 | |
| FXE | Speculum, Non-Illuminated | 1 | 0 | |
| FXF | Speculum, Illuminated | 1 | 1 | |
| FXG | Specula Accessories | 1 | 1 | |
| JYK | Holder, Ear Speculum | 1 | 1 | |
| KAG | Holder, Speculum, Ent | 1 | 2 |
