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510(k) K960949

PROSYS BEDSIDE DRAINAGE BAG (STERILE) MODEL 650167 by Bristol-Myers Squibb — Product Code KNX

K960949 is an FDA 510(k) premarket notification submitted by Bristol-Myers Squibb for the device "PROSYS BEDSIDE DRAINAGE BAG (STERILE) MODEL 650167". The FDA issued a decision of Substantially Equivalent on April 19, 1996. 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
April 19, 1996
Date Received
March 11, 1996
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)
  • 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)
  • K952208 — PROSYS LEG BAG (August 15, 1995)

FDA data resources