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510(k) K772133

URINE SPECIMEN COLLECTING DEVICE by Kendall Research Center — Product Code FCN

K772133 is an FDA 510(k) premarket notification submitted by Kendall Research Center for the device "URINE SPECIMEN COLLECTING DEVICE". The FDA issued a decision of Substantially Equivalent on November 28, 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. Kendall Research Center has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 28, 1977
Date Received
November 14, 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 Kendall Research Center

  • K802225 — TENDER-SORB DRAIN SPONGES (September 26, 1980)
  • K781357 — T.E.D. SEQUENTIAL COMPRESSION SLEEVES (September 20, 1978)
  • K780408 — MICRONET LIGHT DRESSING SPONGE (March 22, 1978)
  • K780062 — CATHETER/HEMOSTATIC/GERIATRIC (February 14, 1978)
  • K780120 — ANESTHESIA TRAY, CAUDAL (February 6, 1978)
  • K772134 — SYRINGE, IRRIGATION, PRE-FILLED (November 28, 1977)
  • K771655 — CURITY PEAKOMETER (October 14, 1977)
  • K771079 — CURITY IRRIGATION TRAY (September 15, 1977)
  • K771452 — CONFORM STRETCH BANDAGE (5SIZES) (September 12, 1977)
  • K771563 — CONFORM ELASTIC NETTING (September 12, 1977)

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)
  • K771210 — UROGARD URINARY DRAINAGE BAG (July 11, 1977)

FDA data resources