FDA product code FGF: Catheter, Ureteral Disposable (X-Ray)
FGF is the FDA product code for catheter, ureteral disposable (x-ray). It is a Class II device, regulated under 21 CFR 876.5130 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 1 510(k) submission under FGF. The average 510(k) review took 51 days (median 51).
Classification
| Field | Value |
|---|---|
| Device name | Catheter, Ureteral Disposable (X-Ray) |
| Device class | Class II |
| Regulation | 21 CFR 876.5130 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every FGF clearance
Top FGF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Applied Urology, Inc. | 1 | 1990-10-19 |
Most recent FGF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K903994 | Applied Urology, Inc. | URETEROPYELOGRAM CATH FOR RETROGRADE DYE INJECTION | 1990-10-19 | 51 |
Recalls for FGF devices
openFDA lists no recalls for product code FGF.
Frequently asked questions
What is FDA product code FGF?
FGF is the FDA product code for catheter, ureteral disposable (x-ray). It is a Class II device, regulated under 21 CFR 876.5130 and reviewed by the Gastroenterology and Urology panel.
What device class is FGF?
Class II, regulation 21 CFR 876.5130. Typical premarket route: 510(k).
How long does a 510(k) take for product code FGF?
Across 1 cleared submissions the average was 51 days from receipt to decision (median 51).
Which companies have the most FGF clearances?
Applied Urology, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code FGF
- Run a recall and safety report across every FGF manufacturer
- Watch product code FGF 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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