FDA product code FGC: Urethroscope
FGC is the FDA product code for urethroscope. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 3 510(k) submissions under FGC, from 3 different applicants. The average 510(k) review took 89 days (median 83).
Classification
| Field | Value |
|---|---|
| Device name | Urethroscope |
| Device class | Class II |
| Regulation | 21 CFR 876.1500 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every FGC clearance
Top FGC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Percuvision, LLC | 1 | 2009-08-25 |
| KARL STORZ Endoscopy-America, Inc. | 1 | 1995-05-12 |
| Kli | 1 | 1980-05-14 |
Most recent FGC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K091600 | Percuvision, LLC | DIRECTVISION GUIDE SYSTEM | 2009-08-25 | 83 |
| K945907 | KARL STORZ Endoscopy-America, Inc. | KARL STORZ SEMI-RIGID MICRO-ENDOSCOPES AND ACCESSORIES FOR ADULT AND PEDIATRIC ENDOSCOPIC UROLOGY PROCEDURES | 1995-05-12 | 161 |
| K800913 | Kli | GYNECOLOGICAL CYSTO/URETHROSCOPE | 1980-05-14 | 23 |
Recalls for FGC devices
openFDA lists no recalls for product code FGC.
Frequently asked questions
What is FDA product code FGC?
FGC is the FDA product code for urethroscope. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel.
What device class is FGC?
Class II, regulation 21 CFR 876.1500. Typical premarket route: 510(k).
How long does a 510(k) take for product code FGC?
Across 3 cleared submissions the average was 89 days from receipt to decision (median 83).
Which companies have the most FGC clearances?
Percuvision, LLC (1); KARL STORZ Endoscopy-America, Inc. (1); Kli (1).
Next steps
- Run an FDA pathway report with predicate devices for product code FGC
- Run a recall and safety report across every FGC manufacturer
- Watch product code FGC 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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