Uro-Pro 2000

No FDA recalls on record, checked 10 Oct 2026.

510(k) Number

K922476 ↗

FDA Product Code

FAP

Device Class

Class II

Regulation

21 CFR Part 876.1620

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• FST Disposable Fiber Optic Transducer #0100-00

  Class II

  FDA 510(k) K864000 Active Cleared 16 Jan 1987

• Fst Cath-Ud, Catheter

  Class II

  FDA 510(k) K950908 Active Cleared 7 Apr 1995

• Fst Cath Ud-Dual Dual Pressure Catheter

  Class II

  FDA 510(k) K926088 Active Cleared 18 Jun 1993

• Fst Cath - Ui Usrodynamic Cath Introducer System

  Class II

  FDA 510(k) K913721 Active Cleared 8 Oct 1991

• 4-Channel Urodynamic Monitor with Uro-Flo Option

  Class II

  FDA 510(k) K945495 Active Cleared 9 Feb 1995

• Fst Cath-Ud Catheter, Modification

  Class II

  FDA 510(k) K913113 Active Cleared 9 Oct 1991

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