FWH · Camera, Cine, Surgical, Without Audio
General, Plastic Surgery · 21 CFR 878.4160 · Class 1
Overview
| Product Code | FWH |
|---|---|
| Device Name | Camera, Cine, Surgical, Without Audio |
| 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.
Cleared Devices (2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K884039 | MEDICAL DYNAMICS SOLID STATE VIDEO CAMERA 5940 | Medical Dynamics, Inc. | Oct 13, 1988 | SESE |
| K823516 | ESA CAMERA | Concept, Inc. | Dec 30, 1982 | SESE |
Top Applicants
- Medical Dynamics, Inc. — 1 clearance
- Concept, Inc. — 1 clearance
