Camera, Television, Microsurgical, Without Audio
A microsurgical television camera without audio is a video imaging device used to capture high-magnification images of the operative field during microsurgical procedures, without audio recording 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 FWD, 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
- FWD
- 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 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K891236 | FDX SOLID STATE VIDEO CAMERA MODEL 5950 | Apr 05, 1989 | Substantially Equivalent | Medical Dynamics, Inc. |
| K882166 | JEDMED MICRO CCD CAMERA SYSTEM | Jun 15, 1988 | Substantially Equivalent | Jedmed Instrument Co. |
| K862664 | JEDMED CCD CAMERA SYSTEM | Jul 30, 1986 | Substantially Equivalent | Jedmed Instrument Co. |
| K862145 | JEDMED MINI-MOS VIDEO CAMERA | Jun 13, 1986 | Substantially Equivalent | Jedmed Instrument Co. |
| K862034 | JEDMED CCD-02 VIDEO CAMERA SYSTEM | Jun 09, 1986 | Substantially Equivalent | Jedmed Instrument Co. |
FEI Numbers
This FDA classification entry is associated with 9 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 9 registration numbers. Click on an entry to view related FDA registrations.