Description
510(k)Checklistfor Mechanical Lithotripters and Stone Dislodgers used in Gastroenterology and Urology.
Scope & Applicability
Product Classes
378 LQC, Class II, 21 CFR 876.4500
78 LQR, Class II, 21 CFR 876.5010
78 FFL, Class II, 21 CFR 876.4680
Regulatory Context
Attributes
1support the use of the proposed cycle and the desired sterility assurance level
Related CFR Sections (3)
- 21CFR876.4500§ 876.4500 Mechanical lithotriptor.
(a) Identification. A mechanical lithotriptor is a device with steel jaws that is inserted into the urinary bladder through the urethra to grasp and crush bladder stones.Read full regulation →
- 21CFR876.5010§ 876.5010 Biliary catheter and accessories.
(a) Identification. A biliary catheter and accessories is a tubular flexible device used for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. This generic type of device may include a bile collecting baRead full regulation →
- 21CFR876.4680§ 876.4680 Ureteral stone dislodger.
(a) Identification. A ureteral stone dislodger is a device that consists of a bougie or a catheter with an expandable wire basket near the tip, a special flexible tip, or other special construction. It is inserted through a cystoscope and used to entrap and remove stones from the ureter. This generiRead full regulation →