FDA product code FWG: Camera, Television, Endoscopic, With Audio
FWG is the FDA product code for camera, television, endoscopic, with 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 2 510(k) submissions under FWG, from 2 different applicants. The average 510(k) review took 84 days (median 84).
Classification
| Field | Value |
|---|---|
| Device name | Camera, Television, Endoscopic, With 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 FWG clearance
Top FWG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Richard Wolf Medical Instruments Corp. | 1 | 1994-03-07 |
| Vistek Corp. | 1 | 1986-02-07 |
Most recent FWG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K934883 | Richard Wolf Medical Instruments Corp. | 3D VIDEO SYSTEM | 1994-03-07 | 146 |
| K860173 | Vistek Corp. | VIS-2000 VIDEO SYSTEM | 1986-02-07 | 21 |
Recalls for FWG devices
openFDA lists no recalls for product code FWG.
Frequently asked questions
What is FDA product code FWG?
FWG is the FDA product code for camera, television, endoscopic, with 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 FWG?
Class I, regulation 21 CFR 878.4160. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code FWG?
Across 2 cleared submissions the average was 84 days from receipt to decision (median 84).
Which companies have the most FWG clearances?
Richard Wolf Medical Instruments Corp. (1); Vistek Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code FWG
- Run a recall and safety report across every FWG manufacturer
- Watch product code FWG 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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