FDA product code FWF: Camera, Television, Endoscopic, Without Audio
FWF is the FDA product code for camera, television, 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 23 510(k) submissions under FWF, from 21 different applicants. The average 510(k) review took 97 days (median 78). FDA has posted 2 recalls for FWF devices.
Classification
| Field | Value |
|---|---|
| Device name | Camera, Television, 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 FWF clearance
Top FWF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Angiolaz, Inc. | 3 | 1998-09-10 |
| Schoelly Imaging, Inc. | 1 | 2006-02-23 |
| Karl Storz Imaging, Inc. | 1 | 1999-06-01 |
| A.Stein - Regulatory Affairs Consulting | 1 | 1999-01-08 |
| Richard Wolf Medical Instruments Corp. | 1 | 1998-11-23 |
16 more applicants have FWF clearances. See the full list in Caduvo.
Most recent FWF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K053412 | Schoelly Imaging, Inc. | FLEXISCOPE, MODELS 50MH AND 50 MHC | 2006-02-23 | 78 |
| K990154 | Karl Storz Imaging, Inc. | KARL STORZ DIRECT COUPLED INTERFACE (DCI 5) CAMERA SYSTEM | 1999-06-01 | 133 |
| K982754 | A.Stein - Regulatory Affairs Consulting | EC-1000-7 DIGITAL ENDOSCOPY VIDEO CAMERA, MODELS EC 1000-7P (PAL) & EC 1000-7N (NTSC) | 1999-01-08 | 155 |
| K982965 | Richard Wolf Medical Instruments Corp. | ENDOCAM CAMERA SYSTEMS 5502/5507 WITH CR CAMERA HEADS AND ACCESSORIES | 1998-11-23 | 90 |
| K982397 | Angiolaz, Inc. | VES 3001-M COMPLETE VIDEO ENDOSCOPIC SYSTEM | 1998-09-10 | 63 |
Recalls for FWF devices
2 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2007-01-19.
Frequently asked questions
What is FDA product code FWF?
FWF is the FDA product code for camera, television, 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 FWF?
Class I, regulation 21 CFR 878.4160. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code FWF?
Across 23 cleared submissions the average was 97 days from receipt to decision (median 78).
Which companies have the most FWF clearances?
Angiolaz, Inc. (3); Schoelly Imaging, Inc. (1); Karl Storz Imaging, Inc. (1); A.Stein - Regulatory Affairs Consulting (1); Richard Wolf Medical Instruments Corp. (1).
Have FWF devices been recalled?
Yes: 2 product recalls across 1 recall events; the most recent began 2007-01-19.
Next steps
- Run an FDA pathway report with predicate devices for product code FWF
- Run a recall and safety report across every FWF manufacturer
- Watch product code FWF 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