FWD · Camera, Television, Microsurgical, Without Audio
General, Plastic Surgery · 21 CFR 878.4160 · Class 1
Overview
| Product Code | FWD |
|---|---|
| Device Name | Camera, Television, Microsurgical, 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 (5 of 5)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K891236 | FDX SOLID STATE VIDEO CAMERA MODEL 5950 | Medical Dynamics, Inc. | Apr 5, 1989 | SESE |
| K882166 | JEDMED MICRO CCD CAMERA SYSTEM | Jedmed Instrument Co. | Jun 15, 1988 | SESE |
| K862664 | JEDMED CCD CAMERA SYSTEM | Jedmed Instrument Co. | Jul 30, 1986 | SESE |
| K862145 | JEDMED MINI-MOS VIDEO CAMERA | Jedmed Instrument Co. | Jun 13, 1986 | SESE |
| K862034 | JEDMED CCD-02 VIDEO CAMERA SYSTEM | Jedmed Instrument Co. | Jun 9, 1986 | SESE |
Top Applicants
- Jedmed Instrument Co. — 4 clearances
- Medical Dynamics, Inc. — 1 clearance
