FWC · Camera, Television, Surgical, With Audio
General, Plastic Surgery · 21 CFR 878.4160 · Class 1
Overview
| Product Code | FWC |
|---|---|
| Device Name | Camera, Television, Surgical, With 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.
Recent Cleared Devices (3 of 3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K890119 | BR-S601MU (SURGICAL VIDEO RECORDER) | Victor Co. of Japan, Ltd. C/O Jvc Corp. | Jan 24, 1989 | SESE |
| K864381 | LUXTEC VIDEOLUX 20/20 CAMERA HEADLIGHT SYSTEM | Luxtec Corp. | Dec 9, 1986 | SESE |
| K854988 | KY-M280U SURGICAL CAMERA | Us Jvc Corp. | Jan 24, 1986 | SESE |
Top Applicants
- Luxtec Corp. — 1 clearance
- Us Jvc Corp. — 1 clearance
- Victor Co. of Japan, Ltd. C/O Jvc Corp. — 1 clearance
