Cpr Urine Bag

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K960217 ↗

FDA Product Code

FAQ

Device Class

Class I

Regulation

21 CFR Part 876.5250

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Cpr Ortho Hand Pack

  Class II

  FDA 510(k) K960210 Active Cleared 12 Apr 1996

• Cpr Laceration Tray

  Class II

  FDA 510(k) K960207 Active Cleared 27 Feb 1996

• Cpr Heart Pack

  Class II

  FDA 510(k) K960209 Active Cleared 4 Apr 1996

• Cpr C-Section Delivery Pack

  Class II

  FDA 510(k) K960243 Active Cleared 23 May 1996

• Cpr Eye Tray

  Class II

  FDA 510(k) K960242 Active Cleared 12 Mar 1996

• Cpr General Surgery Tray

  Class II

  FDA 510(k) K960241 Active Cleared 22 Mar 1996

See all devices from Custom Pack Reliability →