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Lithotriptor, Ultrasonic

Page Type
Product Code
Regulation Medical Specialty
Gastroenterology and Urology
Review Panel
Gastroenterology and Urology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
876.4480
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 876.4480 Electrohydraulic lithotriptor

§ 876.4480 Electrohydraulic lithotriptor.

(a) 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.

(b) Classification. Class II. The special control for this device is FDA's “Guidance for the Content of Premarket Notifications for Intracorporeal Lithotripters.”

[48 FR 53023, Nov. 23, 1983, as amended at 52 FR 17738, May 11, 1987; 65 FR 17145, Mar. 31, 2000]

Lithotriptor, Ultrasonic

Page Type
Product Code
Regulation Medical Specialty
Gastroenterology and Urology
Review Panel
Gastroenterology and Urology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
876.4480
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 876.4480 Electrohydraulic lithotriptor

§ 876.4480 Electrohydraulic lithotriptor.

(a) 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.

(b) Classification. Class II. The special control for this device is FDA's “Guidance for the Content of Premarket Notifications for Intracorporeal Lithotripters.”

[48 FR 53023, Nov. 23, 1983, as amended at 52 FR 17738, May 11, 1987; 65 FR 17145, Mar. 31, 2000]