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510(k) K890550

CP&S DISPOSABLE URINARY LEGBAG (MEDIUM & LARGE) by Consolidated Products & Services, Inc. — Product Code KNX

K890550 is an FDA 510(k) premarket notification submitted by Consolidated Products & Services, Inc. for the device "CP&S DISPOSABLE URINARY LEGBAG (MEDIUM & LARGE)". The FDA issued a decision of Substantially Equivalent on February 28, 1989. The device falls under product code KNX (Collector, Urine, (And Accessories) For Indwelling Catheter), a Class II device regulated under 21 CFR 876.5250. Consolidated Products & Services, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 28, 1989
Date Received
February 6, 1989
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 Consolidated Products & Services, Inc.

  • K974190 — CP&S INSTANT COLD PACK LIMB KIT TRANSPORTER (November 19, 1997)
  • K930759 — CP & S STERILE BURN SHEET (January 21, 1994)
  • K890551 — URINARY DRAINAGE UNIT (February 28, 1989)
  • K890552 — CP&S GAVAGE CONSTAINER, DISPOSABLE (February 24, 1989)
  • K890554 — CP&S DISPOSABLE INSTANT SUPER HOT COMPRESS (February 13, 1989)
  • K890553 — CP&S DISPOSABLE INSTANT COLD COMPRESS (February 13, 1989)

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