Urine Bag System

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K831796 ↗

FDA Product Code

KNX

Device Class

Class II

Regulation

21 CFR Part 876.5250

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Umbilical Cord Clamp

  Class II

  FDA 510(k) K880753 Active Cleared 27 Apr 1988

• Syringe Prefilled with Water

  Class II

  FDA 510(k) K881363 Active Cleared 23 Jun 1988

• Sets & Trays

  Not classified

  FDA 510(k) K831794 Active Cleared 16 Aug 1983

• Hemostats

  Class I

  FDA 510(k) K831797 Active Cleared 19 Jul 1983

• Coccidioides Mycelial Antigen

  Class II

  FDA 510(k) K760829 Active Cleared 1 Nov 1976

• Blastomyces Yeast Antigen

  Class I

  FDA 510(k) K760828 Active Cleared 1 Nov 1976

See all devices from I M, Inc. →