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510(k) K823274

UNI-TIP COLOSTOMY IRRIGATION CONE by Howmedica Corp. — Product Code EXD

K823274 is an FDA 510(k) premarket notification submitted by Howmedica Corp. for the device "UNI-TIP COLOSTOMY IRRIGATION CONE". The FDA issued a decision of Substantially Equivalent on December 7, 1982. The device falls under product code EXD (Irrigator, Ostomy), a Class II device regulated under 21 CFR 876.5895. Howmedica Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 7, 1982
Date Received
November 3, 1982
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 Howmedica Corp.

  • K984251 — XIA SPINE SYSTEM (February 24, 1999)
  • K984202 — HOWMEDICA HUMERAL INTERCALARY SYSTEM (February 5, 1999)
  • K984305 — ZETA MULTIZONE LOCKING NAIL SYSTEM (February 1, 1999)
  • K983885 — BURR HOLE COVERS, CRANIOMAXILLOFACIAL PLATES (January 29, 1999)
  • K983528 — MICRO DYNAMIC MESH (December 23, 1998)
  • K983404 — TYPE 3 FEMORAL COMPONENTS (December 22, 1998)
  • K980925 — DURATION II TIBIAL INSERTS-ETHYLENE OXIDE STERILIZATION (December 16, 1998)
  • K980926 — DURATION II ACETABULAR COMPONENTS-ETHYLENE OXIDE STERILIZATION (December 16, 1998)
  • K980626 — DURATION II ACETABULAR COMPONENTS-GAS PLASMA STERILIZATION (December 11, 1998)
  • K980632 — DURATION II TIBIAL INSERTS - GAS PLASMA STERILIZATION (December 11, 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)
  • K832299 — VISI-FLOW IRRIGATOR (August 26, 1983)
  • K811160 — SUR-FIT IRRIGATION SLEEVE (June 2, 1981)
  • K790749 — COLOSTOMY ENEMA DEVICE (May 16, 1979)
  • K790750 — COLOSTOMY DEVICE W/ PRESSURE LID (May 14, 1979)
  • K760810 — TUBE, GASTRO-ENTEROSTOMY (February 28, 1977)

FDA data resources