Camera, Television, Surgical, Without Audio
A surgical television camera without audio is a video recording device used in the operating room to capture live or recorded imagery of surgical procedures for documentation, telemetry, or teaching, without audio capability. It is classified as FDA Class 1 (lowest risk), subject to general controls only, and does not require premarket notification. The product code is FWB, regulated under 21 CFR 878.4160, within the General, Plastic Surgery medical specialty. No special flags apply to this device.
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Basic Information
- Product Code
- FWB
- Device Class
- FDA class 1
- Regulation Number
- 878.4160
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 6 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K934092 | CAMERA, SURGICAL AND ACCESSORIES | Jan 07, 1994 | Substantially Equivalent | Envision Medical Corp. |
| K902359 | SURGICAL VIDEO CAMERA, MODEL 9500 | Jul 12, 1990 | Substantially Equivalent | Seitz Technical Products, Inc. |
| K884343 | SONY COLOR VIDEO CAMERAS AND ACCESSORIES | Nov 01, 1988 | Substantially Equivalent | Sony Corp. of America |
| K871057 | MC-SERIES SURGICAL CAMERAS | Apr 03, 1987 | Substantially Equivalent | M.P. Video, Inc. |
| K855020 | MEDICAL DYNAMICS CCD SOLID STATE VIDEO CAMERA 5930 | Jan 24, 1986 | Substantially Equivalent | Medline Industries, Inc. |
| K820829 | MEDICAM | May 03, 1982 | Substantially Equivalent | M.P. Video, Inc. |
FEI Numbers
This FDA classification entry is associated with 35 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 35 registration numbers. Click on an entry to view related FDA registrations.