FDA product code FWB: Camera, Television, Surgical, Without Audio
FWB is the FDA product code for camera, television, 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 6 510(k) submissions under FWB, from 5 different applicants. The average 510(k) review took 49 days (median 39). FDA has posted 2 recalls for FWB devices.
Classification
| Field | Value |
|---|---|
| Device name | Camera, Television, 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 FWB clearance
Top FWB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| M.P. Video, Inc. | 2 | 1987-04-03 |
| Envision Medical Corp. | 1 | 1994-01-07 |
| Seitz Technical Products, Inc. | 1 | 1990-07-12 |
| Sony Corp. of America | 1 | 1988-11-01 |
| Medline Industries, Inc. | 1 | 1986-01-24 |
Most recent FWB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K934092 | Envision Medical Corp. | CAMERA, SURGICAL AND ACCESSORIES | 1994-01-07 | 137 |
| K902359 | Seitz Technical Products, Inc. | SURGICAL VIDEO CAMERA, MODEL 9500 | 1990-07-12 | 44 |
| K884343 | Sony Corp. of America | SONY COLOR VIDEO CAMERAS AND ACCESSORIES | 1988-11-01 | 18 |
| K871057 | M.P. Video, Inc. | MC-SERIES SURGICAL CAMERAS | 1987-04-03 | 17 |
| K855020 | Medline Industries, Inc. | MEDICAL DYNAMICS CCD SOLID STATE VIDEO CAMERA 5930 | 1986-01-24 | 39 |
Recalls for FWB devices
2 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2017-12-15.
| Year | Recalls |
|---|---|
| 2017 | 1 |
Frequently asked questions
What is FDA product code FWB?
FWB is the FDA product code for camera, television, 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 FWB?
Class I, regulation 21 CFR 878.4160. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code FWB?
Across 6 cleared submissions the average was 49 days from receipt to decision (median 39).
Which companies have the most FWB clearances?
M.P. Video, Inc. (2); Envision Medical Corp. (1); Seitz Technical Products, Inc. (1); Sony Corp. of America (1); Medline Industries, Inc. (1).
Have FWB devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2017-12-15.
Next steps
- Run an FDA pathway report with predicate devices for product code FWB
- Run a recall and safety report across every FWB manufacturer
- Watch product code FWB 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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