FDA product code FWC: Camera, Television, Surgical, With Audio
FWC is the FDA product code for camera, television, surgical, 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 3 510(k) submissions under FWC, from 3 different applicants. The average 510(k) review took 30 days (median 34).
Classification
| Field | Value |
|---|---|
| Device name | Camera, Television, Surgical, 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 FWC clearance
Top FWC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Victor Co. of Japan, Ltd. C/O Jvc Corp. | 1 | 1989-01-24 |
| Luxtec Corp. | 1 | 1986-12-09 |
| Us Jvc Corp. | 1 | 1986-01-24 |
Most recent FWC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K890119 | Victor Co. of Japan, Ltd. C/O Jvc Corp. | BR-S601MU (SURGICAL VIDEO RECORDER) | 1989-01-24 | 13 |
| K864381 | Luxtec Corp. | LUXTEC VIDEOLUX 20/20 CAMERA HEADLIGHT SYSTEM | 1986-12-09 | 34 |
| K854988 | Us Jvc Corp. | KY-M280U SURGICAL CAMERA | 1986-01-24 | 43 |
Recalls for FWC devices
openFDA lists no recalls for product code FWC.
Frequently asked questions
What is FDA product code FWC?
FWC is the FDA product code for camera, television, surgical, 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 FWC?
Class I, regulation 21 CFR 878.4160. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code FWC?
Across 3 cleared submissions the average was 30 days from receipt to decision (median 34).
Which companies have the most FWC clearances?
Victor Co. of Japan, Ltd. C/O Jvc Corp. (1); Luxtec Corp. (1); Us Jvc Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code FWC
- Run a recall and safety report across every FWC manufacturer
- Watch product code FWC 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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