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510(k) K771210

UROGARD URINARY DRAINAGE BAG by Terumo America, Inc. — Product Code FCN

K771210 is an FDA 510(k) premarket notification submitted by Terumo America, Inc. for the device "UROGARD URINARY DRAINAGE BAG". The FDA issued a decision of Substantially Equivalent on July 11, 1977. The device falls under product code FCN (Urinary Drainage Collection Kit, For Indwelling Catheter), a Class II device regulated under 21 CFR 876.5250. Terumo America, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 11, 1977
Date Received
July 5, 1977
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 Terumo America, Inc.

  • K811523 — PLASMA FLEX (September 9, 1981)
  • K802970 — TERUMO HOLLOW FIBER OXYGENATOR (January 22, 1981)
  • K802441 — CLIRANS TH10 HOLLOW FIBER DIALYZER (December 18, 1980)
  • K802122 — CLIRANS TH13 HOLLOW FIBER DIALYZER (December 18, 1980)
  • K801192 — CLIRANS TE10 HOLLOW FIBER DIALYZER (August 12, 1980)
  • K801193 — CLIRANS TE15 HOLLOW FIBER DIALYZER (August 12, 1980)
  • K801194 — CLIRANS TE07 HOLLOW FIBER DIALYZER (August 12, 1980)
  • K791411 — COAXIAL DUAL FLOW CATHETER (November 13, 1979)
  • K791173 — SURFLO INJECTION PLUG (July 30, 1979)
  • K790105 — TERUMO IMUGARD (May 24, 1979)

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)
  • K883886 — DOUBLE CLOSED URINARY DRAINAGE SYSTEM (December 19, 1988)
  • K883610 — LAKE FOLEY CATHETERIZATION TRAY (October 12, 1988)
  • K780134 — URINARY DRAINAGE MONITORING SYSTEM (February 2, 1978)
  • K772133 — URINE SPECIMEN COLLECTING DEVICE (November 28, 1977)

FDA data resources