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510(k) K971764

WELCON HUE-VU URINARY DRAINAGE BAG by Welcon, Inc. — Product Code KNX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 29, 1997
Date Received
May 13, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Collector, Urine, (And Accessories) For Indwelling Catheter
Device Class
Class II
Regulation Number
876.5250
Review Panel
GU
Submission Type

Other clearances by Welcon, Inc.

  • K003402 — WELCON STERILE WATER FOR DEVICE IRRIGATION; WELCON STERILE 0.9% NORMAL SALINE FO (May 1, 2001)
  • K973734 — STERILE WATER FOR DEVICE IRRIGATION/ STERILE SALINE FOR DEVICE IRRIGATION (February 5, 1998)
  • K912869 — WOMEN AND INFANT'S DELIVERY PACK (December 4, 1991)
  • K904158 — ACCORDE(R) IRRIGATING SYRINGE/PROCEDURE TRAY (November 29, 1990)
  • K894397 — WELCON LIGHT HANDLE (August 10, 1989)
  • K830359 — STERILE CATHERIZATION PROCEDURE TRAYS (March 17, 1983)
  • K813027 — STERILE IRRIGATING SYRINGES, KITS,TRAY (November 20, 1981)

Other clearances for product code KNX

  • K110518 — IBAG (June 24, 2011)
  • K973364 — 4L DRAINAGE BAG, 4L BAG FOR PERITONEAL DIALYSIS, 4L URINARY DRAINAGE BAG (March 17, 1998)
  • K972887 — MEDLINE PREMIUM LEG BAG, MEDLINE FABRIC BAC LEG BAG, MEDLINE URINARY LEG BAG (December 11, 1997)
  • K971271 — BESECURE EXTERNAL URINARY COLLECTION SYSTEM (August 18, 1997)
  • K971929 — AMSINO URINARY LEG BAG (August 6, 1997)
  • K964690 — LIBERTY VALVE (March 21, 1997)
  • K964745 — AMSINO URINARY DRAINAGE BAG (March 18, 1997)
  • K962652 — URINARY DRAINAGE BAG, (REORDER NO. 0749 - PRODUCT NO. 900-749) (October 4, 1996)
  • K960949 — PROSYS BEDSIDE DRAINAGE BAG (STERILE) MODEL 650167 (April 19, 1996)
  • K952208 — PROSYS LEG BAG (August 15, 1995)