FWL · Camera, Cine, Endoscopic, Without Audio
General, Plastic Surgery · 21 CFR 878.4160 · Class 1
Overview
| Product Code | FWL |
|---|---|
| Device Name | Camera, Cine, Endoscopic, 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 (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K951519 | WECO ENDOSCOPIC SYSTEM WITH FIBER OPTIC LIGHT | Wells Johnson Co. | Jun 14, 1995 | SESE |
| K883760 | STORZ MODEL 62 ENT CAMERA SYSTEM | Storz Instrument Co. | Sep 28, 1988 | SESE |
Top Applicants
- Storz Instrument Co. — 1 clearance
- Wells Johnson Co. — 1 clearance
