FFE · System, Water Jet Catheter, Renal
Gastroenterology, Urology · 21 CFR 876.4650 · Class 2
Overview
| Product Code | FFE |
|---|---|
| Device Name | System, Water Jet Catheter, Renal |
| Regulation | 21 CFR 876.4650 |
| Device Class | Class 2 |
| Review Panel | Gastroenterology, Urology |
Identification
A water jet renal stone dislodger system is a device used to dislodge stones from renal calyces (recesses of the pelvis of the kidney) by means of a pressurized stream of water through a conduit. The device is used in the surgical removal of kidney stones.
Classification Rationale
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.
Cleared Devices (1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K971328 | OLYMPUS CD-6C-1 COAGULATION ELECTRODE | Olympus America, Inc. | Jul 1, 1997 | SESE |
Top Applicants
- Olympus America, Inc. — 1 clearance
