FDA product code FGH: Catheter, Double Lumen Female Urethrographic
FGH is the FDA product code for catheter, double lumen female urethrographic. 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 FGH. The average 510(k) review took 70 days (median 70).
Classification
| Field | Value |
|---|---|
| Device name | Catheter, Double Lumen Female Urethrographic |
| 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 FGH clearance
Top FGH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| C.R. Bard, Inc. | 1 | 1991-03-27 |
Most recent FGH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K910196 | C.R. Bard, Inc. | BARD HYDROGEL-COATED DIAGNOSTIC URETHRAL CATHETERS | 1991-03-27 | 70 |
Recalls for FGH devices
openFDA lists no recalls for product code FGH.
Frequently asked questions
What is FDA product code FGH?
FGH is the FDA product code for catheter, double lumen female urethrographic. It is a Class II device, regulated under 21 CFR 876.5130 and reviewed by the Gastroenterology and Urology panel.
What device class is FGH?
Class II, regulation 21 CFR 876.5130. Typical premarket route: 510(k).
How long does a 510(k) take for product code FGH?
Across 1 cleared submissions the average was 70 days from receipt to decision (median 70).
Which companies have the most FGH clearances?
C.R. Bard, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code FGH
- Run a recall and safety report across every FGH manufacturer
- Watch product code FGH 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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