FDA product code FWD: Camera, Television, Microsurgical, Without Audio
FWD is the FDA product code for camera, television, microsurgical, without audio. It is a Class I device, regulated under 21 CFR 878.4160 and reviewed by the General and Plastic Surgery panel. FDA has cleared 5 510(k) submissions under FWD, from 2 different applicants. The average 510(k) review took 17 days (median 16).
Classification
| Field | Value |
|---|---|
| Device name | Camera, Television, Microsurgical, Without Audio |
| Device class | Class I |
| Regulation | 21 CFR 878.4160 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every FWD clearance
Top FWD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Jedmed Instrument Co. | 4 | 1988-06-15 |
| Medical Dynamics, Inc. | 1 | 1989-04-05 |
Most recent FWD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K891236 | Medical Dynamics, Inc. | FDX SOLID STATE VIDEO CAMERA MODEL 5950 | 1989-04-05 | 29 |
| K882166 | Jedmed Instrument Co. | JEDMED MICRO CCD CAMERA SYSTEM | 1988-06-15 | 22 |
| K862664 | Jedmed Instrument Co. | JEDMED CCD CAMERA SYSTEM | 1986-07-30 | 16 |
| K862145 | Jedmed Instrument Co. | JEDMED MINI-MOS VIDEO CAMERA | 1986-06-13 | 9 |
| K862034 | Jedmed Instrument Co. | JEDMED CCD-02 VIDEO CAMERA SYSTEM | 1986-06-09 | 11 |
Recalls for FWD devices
openFDA lists no recalls for product code FWD.
Frequently asked questions
What is FDA product code FWD?
FWD is the FDA product code for camera, television, microsurgical, without audio. It is a Class I device, regulated under 21 CFR 878.4160 and reviewed by the General and Plastic Surgery panel.
What device class is FWD?
Class I, regulation 21 CFR 878.4160. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code FWD?
Across 5 cleared submissions the average was 17 days from receipt to decision (median 16).
Which companies have the most FWD clearances?
Jedmed Instrument Co. (4); Medical Dynamics, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code FWD
- Run a recall and safety report across every FWD manufacturer
- Watch product code FWD for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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