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510(k) K971271

BESECURE EXTERNAL URINARY COLLECTION SYSTEM by Urology Research Intl., Inc. — Product Code KNX

K971271 is an FDA 510(k) premarket notification submitted by Urology Research Intl., Inc. for the device "BESECURE EXTERNAL URINARY COLLECTION SYSTEM". The FDA issued a decision of Substantially Equivalent on August 18, 1997. The device falls under product code KNX (Collector, Urine, (And Accessories) For Indwelling Catheter), a Class II device regulated under 21 CFR 876.5250.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 18, 1997
Date Received
April 4, 1997
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 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)
  • 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)
  • K952208 — PROSYS LEG BAG (August 15, 1995)

FDA data resources