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510(k) K962073

URETHRAL CATHETERIZATION TRAY/UNIVERSAL URETHRAL CATH TRAY by Continental Medical Laboratories, Inc. — Product Code FCM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 21, 1996
Date Received
May 28, 1996
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 Continental Medical Laboratories, Inc.

  • K964827 — PROD. NO. 01-132 - SUTURE REMOVAL KIT (February 14, 1997)
  • K963234 — STAPLE REMOVAL KIT (October 21, 1996)
  • K963443 — PROD. NO. 02-031 - LACERATION TRAY (October 17, 1996)
  • K962078 — TRACHEOSTOMY CLEANING TRAY W/SUCTION CATHETER (October 11, 1996)
  • K954728 — PROD NO. 01-1694 - 4X4 FOAM DRESSING (September 23, 1996)
  • K952335 — WOUND CARE MANAGEMENT KITS (June 14, 1995)
  • K905123 — G-TUBE DRESSING CHANGE TRAY (March 27, 1991)

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)
  • K030664 — AMSURE FOLEY INSERTION TRAY (May 23, 2003)
  • K030712 — AMSURE URETHRAL CATHETERIZATION 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)