FDA product code FWH: Camera, Cine, Surgical, Without Audio
FWH is the FDA product code for camera, cine, surgical, 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 FWH, from 2 different applicants. The average 510(k) review took 24 days (median 24). FDA has posted 1 recall for FWH devices.
Classification
| Field | Value |
|---|---|
| Device name | Camera, Cine, Surgical, 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 FWH clearance
Top FWH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Medical Dynamics, Inc. | 1 | 1988-10-13 |
| Concept, Inc. | 1 | 1982-12-30 |
Most recent FWH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K884039 | Medical Dynamics, Inc. | MEDICAL DYNAMICS SOLID STATE VIDEO CAMERA 5940 | 1988-10-13 | 17 |
| K823516 | Concept, Inc. | ESA CAMERA | 1982-12-30 | 31 |
Recalls for FWH devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2012-07-10.
Frequently asked questions
What is FDA product code FWH?
FWH is the FDA product code for camera, cine, surgical, 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 FWH?
Class I, regulation 21 CFR 878.4160. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code FWH?
Across 2 cleared submissions the average was 24 days from receipt to decision (median 24).
Which companies have the most FWH clearances?
Medical Dynamics, Inc. (1); Concept, Inc. (1).
Have FWH devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2012-07-10.
Next steps
- Run an FDA pathway report with predicate devices for product code FWH
- Run a recall and safety report across every FWH manufacturer
- Watch product code FWH 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.
All General and Plastic Surgery product codes · FDA product code lookup · 510(k) database search · 510(k) review times