Home / 510(k) Clearances / K904158

510(k) K904158

ACCORDE(R) IRRIGATING SYRINGE/PROCEDURE TRAY by Welcon, Inc. — Product Code FCM

Clearance Details

Decision
SEKD (Substantially Equivalent (kit, denovo))
Decision Date
November 29, 1990
Date Received
September 7, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)
Device Class
Class II
Regulation Number
876.5130
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)
  • K971764 — WELCON HUE-VU URINARY DRAINAGE BAG (July 29, 1997)
  • K912869 — WOMEN AND INFANT'S DELIVERY PACK (December 4, 1991)
  • 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 FCM

  • K250891 — Cure Catheter Insertion Kit (K1); Cure Catheter Insertion Kit (K2); Cure Cathete (June 6, 2025)
  • K223821 — Self-Cath Closed System (August 2, 2023)
  • K082831 — AMSELF CLOSED CATHETERIZATION SYSTEM (October 23, 2008)
  • K070939 — SELF-CATH CS CLOSED URINARY CATHETERIZATION SYSTEM (June 1, 2007)
  • K070048 — GUARDIAN CATHETER-INFANT URINARY COLLECTION KIT (March 15, 2007)
  • K030712 — AMSURE URETHRAL CATHETERIZATION TRAY (May 23, 2003)
  • K030664 — AMSURE FOLEY INSERTION TRAY (May 23, 2003)
  • K011055 — THE O'NEIL STERILE FIELD URINARY CATHETER KIT WITH PREP PADS (June 6, 2001)
  • K010420 — RUSCH MMG/O'NEIL CATHETER (May 9, 2001)
  • K003873 — MENTOR SELF-CATH CLOSED SYSTEM (March 29, 2001)