FDA product code FXN: Tape, Camera, Surgical
FXN is the FDA product code for tape, camera, surgical. It is a Class I device, regulated under 21 CFR 878.4160 and reviewed by the General and Plastic Surgery panel. FDA has cleared 4 510(k) submissions under FXN, from 4 different applicants. The average 510(k) review took 186 days (median 196).
Classification
| Field | Value |
|---|---|
| Device name | Tape, Camera, Surgical |
| 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 FXN clearance
Top FXN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Woundvision, LLC | 1 | 2013-12-11 |
| Advanced Planimetric Services, LLC | 1 | 2013-08-30 |
| Aranz Medical Limited | 1 | 2007-06-29 |
| Verg, Inc. | 1 | 1996-12-20 |
Most recent FXN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K131596 | Woundvision, LLC | WOUND MEASURING & MONITORING DEVICE | 2013-12-11 | 191 |
| K130165 | Advanced Planimetric Services, LLC | PICTZAR DIGITAL PLANIMETRY SOFTWARE APPLICATION 7.0 | 2013-08-30 | 219 |
| K070426 | Aranz Medical Limited | SILHOUETTE, MODEL 1000.01 | 2007-06-29 | 136 |
| K962148 | Verg, Inc. | VERGE VIDEOMETER | 1996-12-20 | 200 |
Recalls for FXN devices
openFDA lists no recalls for product code FXN.
Frequently asked questions
What is FDA product code FXN?
FXN is the FDA product code for tape, camera, surgical. 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 FXN?
Class I, regulation 21 CFR 878.4160. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code FXN?
Across 4 cleared submissions the average was 186 days from receipt to decision (median 196).
Which companies have the most FXN clearances?
Woundvision, LLC (1); Advanced Planimetric Services, LLC (1); Aranz Medical Limited (1); Verg, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code FXN
- Run a recall and safety report across every FXN manufacturer
- Watch product code FXN 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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