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510(k) K832526

UROTRACK PLUS by Vital Metrics, Inc. — Product Code KNX

K832526 is an FDA 510(k) premarket notification submitted by Vital Metrics, Inc. for the device "UROTRACK PLUS". The FDA issued a decision of Substantially Equivalent on September 19, 1983. The device falls under product code KNX (Collector, Urine, (And Accessories) For Indwelling Catheter), a Class II device regulated under 21 CFR 876.5250. Vital Metrics, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 19, 1983
Date Received
July 29, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Collector, Urine, (And Accessories) For Indwelling Catheter
Device Class
Class II
Regulation Number
876.5250
Review Panel
GU
Submission Type

Other clearances by Vital Metrics, Inc.

  • K883201 — VITAL-VUE ILLUMINATION, SUCTION & IRRIGATION SYS (September 26, 1988)
  • K882956 — VITAL-VUE ILLUMINATION, SUCTION AND IRRIGATION (August 3, 1988)
  • K844973 — IRRIGA SUC ILLUM ISIS 710 & 7100 SERIES (March 18, 1985)
  • K843441 — URINARY DRAINAGE CONTAINER 2012-WITH (January 3, 1985)
  • K843442 — URINARY DRAINAGE CONTAINER 2013 WITH (January 3, 1985)
  • K840917 — URINARY MONITORING SYS 240 (May 1, 1984)
  • K834448 — URINARY DRAINAGE CONTAINER (February 10, 1984)
  • K813641 — VITAL METRICS URINE MONITORING SYSTEM (March 1, 1982)

Other clearances for product code KNX

  • K110518 — IBAG (June 24, 2011)
  • K973364 — 4L DRAINAGE BAG, 4L BAG FOR PERITONEAL DIALYSIS, 4L URINARY DRAINAGE BAG (March 17, 1998)
  • K972887 — MEDLINE PREMIUM LEG BAG, MEDLINE FABRIC BAC LEG BAG, MEDLINE URINARY LEG BAG (December 11, 1997)
  • K971271 — BESECURE EXTERNAL URINARY COLLECTION SYSTEM (August 18, 1997)
  • K971929 — AMSINO URINARY LEG BAG (August 6, 1997)
  • K971764 — WELCON HUE-VU URINARY DRAINAGE BAG (July 29, 1997)
  • K964690 — LIBERTY VALVE (March 21, 1997)
  • K964745 — AMSINO URINARY DRAINAGE BAG (March 18, 1997)
  • K962652 — URINARY DRAINAGE BAG, (REORDER NO. 0749 - PRODUCT NO. 900-749) (October 4, 1996)
  • K960949 — PROSYS BEDSIDE DRAINAGE BAG (STERILE) MODEL 650167 (April 19, 1996)

FDA data resources