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510(k) K904586

PALEX IRRIGATION SET by Palex Intl. SA — Product Code EXD

K904586 is an FDA 510(k) premarket notification submitted by Palex Intl. SA for the device "PALEX IRRIGATION SET". The FDA issued a decision of Substantially Equivalent on December 28, 1990. The device falls under product code EXD (Irrigator, Ostomy), a Class II device regulated under 21 CFR 876.5895. Palex Intl. SA has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 28, 1990
Date Received
October 9, 1990
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 by Palex Intl. SA

  • K905108 — CONTORNO(R), MODELS E AND ST (February 4, 1991)
  • K903224 — EPISENSOR (December 24, 1990)
  • K902642 — CONTORNO (TM) (August 7, 1990)
  • K901680 — BAUMAN RIGID LARYNGOSCOPE (July 12, 1990)

Other clearances for product code EXD

  • K121833 — OSTOMY IRRIGATION SET (July 16, 2012)
  • K914692 — URINARY DIVERSION EVACUATING CATHETER (July 2, 1992)
  • 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)

FDA data resources