FXQ · Lens, Camera, Surgical
General, Plastic Surgery · 21 CFR 878.4160 · Class 1
Overview
| Product Code | FXQ |
|---|---|
| Device Name | Lens, Camera, Surgical |
| Regulation | 21 CFR 878.4160 |
| Device Class | Class 1 |
| Review Panel | General, Plastic Surgery |
Identification
A surgical camera and accessories is a device intended to be used to record operative procedures.
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 |
|---|---|---|---|---|
| K821705 | NAGASHIMA F60MM ATTACH. LENS | Kelleher Corp. | Jul 9, 1982 | SESE |
Top Applicants
- Kelleher Corp. — 1 clearance
