FDA product code FGI: Catheter, Urethrographic, Male
FGI is the FDA product code for catheter, urethrographic, male. It is a Class II device, regulated under 21 CFR 876.5130 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 3 510(k) submissions under FGI, from 3 different applicants. The average 510(k) review took 86 days (median 90).
Classification
| Field | Value |
|---|---|
| Device name | Catheter, Urethrographic, Male |
| 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 FGI clearance
Top FGI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Vomed Volzer Medizintechnik GmbH & Co. | 1 | 2002-12-10 |
| Neoseed Technology,Llc | 1 | 2002-02-20 |
| Vance Products, Inc. | 1 | 1981-03-20 |
Most recent FGI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K023019 | Vomed Volzer Medizintechnik GmbH & Co. | VOMED URETHRA OLIVE, MODELS 1420 000, 1425 000, 1430 000 | 2002-12-10 | 90 |
| K013360 | Neoseed Technology,Llc | DFINER UROLOGICAL CATHETER | 2002-02-20 | 133 |
| K810370 | Vance Products, Inc. | POLLACK CHAIN CYSOURETHROGRAM SET | 1981-03-20 | 36 |
Recalls for FGI devices
openFDA lists no recalls for product code FGI.
Frequently asked questions
What is FDA product code FGI?
FGI is the FDA product code for catheter, urethrographic, male. It is a Class II device, regulated under 21 CFR 876.5130 and reviewed by the Gastroenterology and Urology panel.
What device class is FGI?
Class II, regulation 21 CFR 876.5130. Typical premarket route: 510(k).
How long does a 510(k) take for product code FGI?
Across 3 cleared submissions the average was 86 days from receipt to decision (median 90).
Which companies have the most FGI clearances?
Vomed Volzer Medizintechnik GmbH & Co. (1); Neoseed Technology,Llc (1); Vance Products, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code FGI
- Run a recall and safety report across every FGI manufacturer
- Watch product code FGI 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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