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510(k) K883886

DOUBLE CLOSED URINARY DRAINAGE SYSTEM by Knight Medical, Inc. — Product Code FCN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 19, 1988
Date Received
September 13, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Urinary Drainage Collection Kit, For Indwelling Catheter
Device Class
Class II
Regulation Number
876.5250
Review Panel
GU
Submission Type

Other clearances by Knight Medical, Inc.

  • K921127 — PANDA NEEDLE CATHETER JEJUNOSTOMY KIT (January 4, 1993)
  • K903086 — TUBE GASTROSTOMY (November 20, 1990)
  • K883848 — KMI OXY-BAN (March 2, 1989)
  • K862489 — ENTERAL FEEDING SETS FOR GRAVITY AND PUMP USE (September 23, 1986)

Other clearances for product code FCN

  • K951443 — STANDARD FOLEY SYSTEM PAK (June 15, 1995)
  • K945258 — CATCO URINARY COLLECTION KIT (February 16, 1995)
  • K915166 — MICROCYCLER (September 7, 1994)
  • K922346 — FEMALE URINE SAMPLING DEVICE (August 14, 1992)
  • K890096 — BLADDER CYCLER CLOSED-SYSTEM URINARY DRAIN BAG (July 14, 1989)
  • K883610 — LAKE FOLEY CATHETERIZATION TRAY (October 12, 1988)
  • K780134 — URINARY DRAINAGE MONITORING SYSTEM (February 2, 1978)
  • K772133 — URINE SPECIMEN COLLECTING DEVICE (November 28, 1977)
  • K771210 — UROGARD URINARY DRAINAGE BAG (July 11, 1977)