Foley Catheter Insertion Tray (10cc)

• • Terminated Z-2154-2014 FDA Class III ·initiated 10 Jul 2014

  Labeling error: The manufacturing date is the same as the expiration date. The manufacturing date is correct, however the expiration date incorrectly indicates that the product is expired.

510(k) Number

K901185 ↗

FDA Product Code

FCM

Device Class

Class II

Regulation

21 CFR Part 876.5130

Advisory Committee

Gastroenterology, Urology

FDA Decision

SEKD

• Pre-Filled Sysringe W/Sterile Water

  Class II

  FDA 510(k) K943829 Active Cleared 21 Nov 1994

• Dual Port Enteral Y-Adaptor

  Class II

  FDA 510(k) K923168 Active Cleared 17 Jun 1994

• External Leg Bag

  Class I

  FDA 510(k) K901219 Active Cleared 27 Jun 1990

• Pre-Filled Syringe W/Sterile 0.9% Sodium Chloride Solution

  Class II

  CE/MDR FDA 510(k) K943830 Active Cleared 21 Nov 1994

• Bulb Irrigation Tray

  Class II

  FDA 510(k) K900736 Active Cleared 17 Apr 1990

• Suction Catheter, Sterile

  Class I

  FDA 510(k) K902814 Active Cleared 17 Aug 1990

See all devices from Orion Life Systems, Inc. →