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510(k) K914692

URINARY DIVERSION EVACUATING CATHETER by Cook Urological, Inc. — Product Code EXD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 2, 1992
Date Received
October 18, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Irrigator, Ostomy
Device Class
Class II
Regulation Number
876.5895
Review Panel
GU
Submission Type

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Other clearances for product code EXD

  • K121833 — OSTOMY IRRIGATION SET (July 16, 2012)
  • K904586 — PALEX IRRIGATION SET (December 28, 1990)
  • K871791 — BLOXOM IRRIGATOR (May 20, 1987)
  • K840268 — IRRIGATION SYSTEM (April 5, 1984)
  • K832299 — VISI-FLOW IRRIGATOR (August 26, 1983)
  • K823274 — UNI-TIP COLOSTOMY IRRIGATION CONE (December 7, 1982)
  • K811160 — SUR-FIT IRRIGATION SLEEVE (June 2, 1981)
  • K790749 — COLOSTOMY ENEMA DEVICE (May 16, 1979)
  • K790750 — COLOSTOMY DEVICE W/ PRESSURE LID (May 14, 1979)
  • K770251 — SUPER X ADJUSTRETTE (February 28, 1977)