FDA product code FXR: Holder, Camera, Surgical
FXR is the FDA product code for holder, 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 2 510(k) submissions under FXR, from 2 different applicants. The average 510(k) review took 30 days (median 30).
Classification
| Field | Value |
|---|---|
| Device name | Holder, 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 FXR clearance
Top FXR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Med Surg Designs, Inc. | 1 | 1985-02-21 |
| The Anspach Effort, Inc. | 1 | 1981-02-26 |
Most recent FXR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K850122 | Med Surg Designs, Inc. | SONI-LOK SCOPE STABILIZER | 1985-02-21 | 38 |
| K810303 | The Anspach Effort, Inc. | TELEVISION CAMERA HOLDER FOR SURGERY | 1981-02-26 | 21 |
Recalls for FXR devices
openFDA lists no recalls for product code FXR.
Frequently asked questions
What is FDA product code FXR?
FXR is the FDA product code for holder, 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 FXR?
Class I, regulation 21 CFR 878.4160. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code FXR?
Across 2 cleared submissions the average was 30 days from receipt to decision (median 30).
Which companies have the most FXR clearances?
Med Surg Designs, Inc. (1); The Anspach Effort, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code FXR
- Run a recall and safety report across every FXR manufacturer
- Watch product code FXR 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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