Camera, Television, Surgical, With Audio
A surgical television camera with audio is a combined video and sound recording device used in operating rooms to document surgical procedures in full audiovisual format for training, consultation, or record-keeping. It is classified as FDA Class 1 (lowest risk), subject to general controls only, and does not require premarket notification. The product code is FWC, 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
- FWC
- 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 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K890119 | BR-S601MU (SURGICAL VIDEO RECORDER) | Jan 24, 1989 | Substantially Equivalent | Victor Co. of Japan, Ltd. C/O Jvc Corp. |
| K864381 | LUXTEC VIDEOLUX 20/20 CAMERA HEADLIGHT SYSTEM | Dec 09, 1986 | Substantially Equivalent | Luxtec Corp. |
| K854988 | KY-M280U SURGICAL CAMERA | Jan 24, 1986 | Substantially Equivalent | Us Jvc Corp. |
FEI Numbers
This FDA classification entry is associated with 18 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 18 registration numbers. Click on an entry to view related FDA registrations.