Ureteral Dilator & Ureteral Stone Dislodger

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K850954 ↗

FDA Product Code

FFL

Device Class

Class II

Regulation

21 CFR Part 876.4680

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• American Edwards Small Diameter Rigid Endoscope

  Class II

  FDA 510(k) K851374 Active Cleared 28 Jun 1985

• Swan-Ganz Flow-Directed Thermodil Cath

  Class II

  FDA 510(k) K822350 Active Cleared 24 Aug 1982

• American Edwards Mini-Flex Angioscope

  Class II

  FDA 510(k) K842481 Active Cleared 18 Oct 1984

• Edslab Pressure Gauge

  Class II

  FDA 510(k) K832323 Active Cleared 11 Aug 1983

• Peripheral Dilatation Angioplasty-Cath

  Class II

  FDA 510(k) K834429 Active Cleared 10 Aug 1984

• Forgarty Balloon Calibrator

  Class II

  FDA 510(k) K830734 Active Cleared 12 Apr 1983

See all devices from American Edwards Laboratories →