FFE — System, Water Jet Catheter, Renal Class II
FDA product code FFE covers "System, Water Jet Catheter, Renal", a Class II medical device regulated under 21 CFR 876.4650. Submissions are reviewed by the Gastroenterology, Urology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- FFE
- Device Class
- Class II
- Regulation Number
- 876.4650
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K971328 | olympus america | OLYMPUS CD-6C-1 COAGULATION ELECTRODE | July 1, 1997 |