External Leg Bag

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K901219 ↗

FDA Product Code

FAQ

Device Class

Class I

Regulation

21 CFR Part 876.5250

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• 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

• 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

• Shave Prep Tray

  Not classified

  FDA 510(k) K902813 Active Cleared 19 Nov 1990

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