Foley Catheters

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K781457 ↗

FDA Product Code

KOD

Device Class

Class II

Regulation

21 CFR Part 876.5130

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Irrigation Tray

  Class II

  FDA 510(k) K781748 Active Cleared 12 Dec 1978

• Non Sterile Parenteral Supply Kit

  Class II

  FDA 510(k) K900857 Active Cleared 22 May 1990

• ReminGel

  Class II

  FDA 510(k) K241489 Active Cleared 8 Jan 2025

• Gen. Purpose Instrument Trays &

  Class I

  FDA 510(k) K833058 Active Cleared 31 Jan 1984

• Sealer Solvent

  Unclassified

  FDA 510(k) K241354 Active Cleared 27 Aug 2024

• Ureteral Stone Dislodger

  Class II

  FDA 510(k) K851922 Active Cleared 2 Aug 1985

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