FDA product code FWL: Camera, Cine, Endoscopic, Without Audio
FWL is the FDA product code for camera, cine, endoscopic, 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 2 510(k) submissions under FWL, from 2 different applicants. The average 510(k) review took 47 days (median 47).
Classification
| Field | Value |
|---|---|
| Device name | Camera, Cine, Endoscopic, 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 FWL clearance
Top FWL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Wells Johnson Co. | 1 | 1995-06-14 |
| Storz Instrument Co. | 1 | 1988-09-28 |
Most recent FWL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K951519 | Wells Johnson Co. | WECO ENDOSCOPIC SYSTEM WITH FIBER OPTIC LIGHT | 1995-06-14 | 72 |
| K883760 | Storz Instrument Co. | STORZ MODEL 62 ENT CAMERA SYSTEM | 1988-09-28 | 22 |
Recalls for FWL devices
openFDA lists no recalls for product code FWL.
Frequently asked questions
What is FDA product code FWL?
FWL is the FDA product code for camera, cine, endoscopic, 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 FWL?
Class I, regulation 21 CFR 878.4160. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code FWL?
Across 2 cleared submissions the average was 47 days from receipt to decision (median 47).
Which companies have the most FWL clearances?
Wells Johnson Co. (1); Storz Instrument Co. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code FWL
- Run a recall and safety report across every FWL manufacturer
- Watch product code FWL 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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