FXR · Holder, Camera, Surgical
General, Plastic Surgery · 21 CFR 878.4160 · Class 1
Overview
| Product Code | FXR |
|---|---|
| Device Name | Holder, 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 (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K850122 | SONI-LOK SCOPE STABILIZER | Med Surg Designs, Inc. | Feb 21, 1985 | SESE |
| K810303 | TELEVISION CAMERA HOLDER FOR SURGERY | The Anspach Effort, Inc. | Feb 26, 1981 | SESE |
Top Applicants
- The Anspach Effort, Inc. — 1 clearance
- Med Surg Designs, Inc. — 1 clearance
