FXG · Specula Accessories
General, Plastic Surgery · 21 CFR 878.1800 · Class 1
Overview
| Product Code | FXG |
|---|---|
| Device Name | Specula Accessories |
| 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 (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K891589 | 3MM DISPOSABLE SPECULA | Semantodontics, Inc. | Apr 18, 1989 | SESE |
Top Applicants
- Semantodontics, Inc. — 1 clearance
