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510(k) K871791

BLOXOM IRRIGATOR by I.B. Bloxom C/O Hogan & Hartson — Product Code EXD

K871791 is an FDA 510(k) premarket notification submitted by I.B. Bloxom C/O Hogan & Hartson for the device "BLOXOM IRRIGATOR". The FDA issued a decision of Substantially Equivalent on May 20, 1987. The device falls under product code EXD (Irrigator, Ostomy), a Class II device regulated under 21 CFR 876.5895.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 20, 1987
Date Received
May 7, 1987
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

Other clearances for product code EXD

  • K121833 — OSTOMY IRRIGATION SET (July 16, 2012)
  • K914692 — URINARY DIVERSION EVACUATING CATHETER (July 2, 1992)
  • K904586 — PALEX IRRIGATION SET (December 28, 1990)
  • 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)

FDA data resources