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510(k) K832299

VISI-FLOW IRRIGATOR by Convatec, A Division of E.R. Squibb & Sons — Product Code EXD

K832299 is an FDA 510(k) premarket notification submitted by Convatec, A Division of E.R. Squibb & Sons for the device "VISI-FLOW IRRIGATOR". The FDA issued a decision of Substantially Equivalent on August 26, 1983. The device falls under product code EXD (Irrigator, Ostomy), a Class II device regulated under 21 CFR 876.5895. Convatec, A Division of E.R. Squibb & Sons has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 26, 1983
Date Received
July 13, 1983
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 Convatec, A Division of E.R. Squibb & Sons

  • K090254 — SILVER IMPREGNATED HYDROFIBER DRESSING REINFORCED WITH NYLON (FLAT) (September 4, 2009)
  • K080383 — AQUACEL HYDROFIBER WOUND DRESSING AND AG HYDROFIBER DRESSING (May 2, 2008)
  • K063271 — AQUACEL HYDROFIBER DRESSING AND AQUACEL AG WITH HYDROFIBER SILVER IMPREGNATED AN (April 16, 2007)
  • K013814 — ABSORBENT ANTIMICROBIAL WOUND DRESSING (June 21, 2002)
  • K990964 — SIGNADRESS DUODERM DRESSING (May 18, 1999)
  • K984388 — HA ABSORBENT WOUND DRESSING (March 3, 1999)
  • K980720 — NONWOVEN PAD (April 15, 1998)
  • K980382 — NON-WOVEN COMPRESS (March 9, 1998)
  • K974823 — NONWOVEN DRESSING (February 20, 1998)
  • K974205 — KNITTED WOUND DRESSING-STANDARD, WCL AND RIBBON (February 6, 1998)

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)
  • K871791 — BLOXOM IRRIGATOR (May 20, 1987)
  • K840268 — IRRIGATION SYSTEM (April 5, 1984)
  • 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