21 CFR 876.4650 — System, Water Jet Catheter, Renal
Gastroenterology, Urology (GU) · Subpart E—Surgical Devices · § 876.4650
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| FFE | System, Water Jet Catheter, Renal | 2 | 1 |
Special Controls
FFE — System, Water Jet Catheter, Renal
*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.
eCFR
