FDA product code FFE: System, Water Jet Catheter, Renal
FFE is the FDA product code for system, water jet catheter, renal. It is a Class II device, regulated under 21 CFR 876.4650 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 1 510(k) submission under FFE. The average 510(k) review took 82 days (median 82).
Classification
| Field | Value |
|---|---|
| Device name | System, Water Jet Catheter, Renal |
| Device class | Class II |
| Regulation | 21 CFR 876.4650 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every FFE clearance
Top FFE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Olympus America, Inc. | 1 | 1997-07-01 |
Most recent FFE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K971328 | Olympus America, Inc. | OLYMPUS CD-6C-1 COAGULATION ELECTRODE | 1997-07-01 | 82 |
Recalls for FFE devices
openFDA lists no recalls for product code FFE.
Frequently asked questions
What is FDA product code FFE?
FFE is the FDA product code for system, water jet catheter, renal. It is a Class II device, regulated under 21 CFR 876.4650 and reviewed by the Gastroenterology and Urology panel.
What device class is FFE?
Class II, regulation 21 CFR 876.4650. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code FFE?
Across 1 cleared submissions the average was 82 days from receipt to decision (median 82).
Which companies have the most FFE clearances?
Olympus America, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code FFE
- Run a recall and safety report across every FFE manufacturer
- Watch product code FFE 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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