FWB · Camera, Television, Surgical, Without Audio
General, Plastic Surgery · 21 CFR 878.4160 · Class 1
Overview
| Product Code | FWB |
|---|---|
| Device Name | Camera, Television, 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.
Recent Cleared Devices (6 of 6)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K934092 | CAMERA, SURGICAL AND ACCESSORIES | Envision Medical Corp. | Jan 7, 1994 | SESE |
| K902359 | SURGICAL VIDEO CAMERA, MODEL 9500 | Seitz Technical Products, Inc. | Jul 12, 1990 | SESE |
| K884343 | SONY COLOR VIDEO CAMERAS AND ACCESSORIES | Sony Corp. of America | Nov 1, 1988 | SESE |
| K871057 | MC-SERIES SURGICAL CAMERAS | M.P. Video, Inc. | Apr 3, 1987 | SESE |
| K855020 | MEDICAL DYNAMICS CCD SOLID STATE VIDEO CAMERA 5930 | Medline Industries, Inc. | Jan 24, 1986 | SESE |
| K820829 | MEDICAM | M.P. Video, Inc. | May 3, 1982 | SESE |
Top Applicants
- M.P. Video, Inc. — 2 clearances
- Envision Medical Corp. — 1 clearance
- Medline Industries, Inc. — 1 clearance
- Seitz Technical Products, Inc. — 1 clearance
- Sony Corp. of America — 1 clearance
