21 CFR 876.4480 — Lithotriptor, Ultrasonic
Gastroenterology, Urology (GU) · Subpart E—Surgical Devices · § 876.4480
Identification
An electrohydraulic lithotriptor is an AC-powered device used to fragment urinary bladder stones. It consists of a high voltage source connected by a cable to a bipolar electrode that is introduced into the urinary bladder through a cystoscope. The electrode is held against the stone in a water-filled bladder and repeated electrical discharges between the two poles of the electrode cause electrohydraulic shock waves which disintegrate the stone.
Classification Rationale
Class II. The special control for this device is FDA's “Guidance for the Content of Premarket Notifications for Intracorporeal Lithotripters.”
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| FEO | Lithotriptor, Ultrasonic | 2 | 14 | 3rd Party |
| FFK | Lithotriptor, Electro-Hydraulic | 2 | 61 | 3rd Party |
Special Controls
FEO — Lithotriptor, Ultrasonic
The special control for this device is FDA's “Guidance for the Content of Premarket Notifications for Intracorporeal Lithotripters.”
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