FDA product code FGK: Tripsor, Stone, Bladder
FGK is the FDA product code for tripsor, stone, bladder. It is a Class II device, regulated under 21 CFR 876.4500 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 1 510(k) submission under FGK. The average 510(k) review took 137 days (median 137).
Classification
| Field | Value |
|---|---|
| Device name | Tripsor, Stone, Bladder |
| Device class | Class II |
| Regulation | 21 CFR 876.4500 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Top FGK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| V. Mueller O.V. Baxter Healthcare Corp. | 1 | 1976-12-06 |
Most recent FGK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K760273 | V. Mueller O.V. Baxter Healthcare Corp. | LITHOTRITE | 1976-12-06 | 137 |
Recalls for FGK devices
openFDA lists no recalls for product code FGK.
Frequently asked questions
What is FDA product code FGK?
FGK is the FDA product code for tripsor, stone, bladder. It is a Class II device, regulated under 21 CFR 876.4500 and reviewed by the Gastroenterology and Urology panel.
What device class is FGK?
Class II, regulation 21 CFR 876.4500. Typical premarket route: 510(k).
How long does a 510(k) take for product code FGK?
Across 1 cleared submissions the average was 137 days from receipt to decision (median 137).
Which companies have the most FGK clearances?
V. Mueller O.V. Baxter Healthcare Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code FGK
- Run a recall and safety report across every FGK manufacturer
- Watch product code FGK 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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