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510(k) K892437

KENDALL KENGUARD URINARY LEG BAGS by The Kendal Co. — Product Code KNX

K892437 is an FDA 510(k) premarket notification submitted by The Kendal Co. for the device "KENDALL KENGUARD URINARY LEG BAGS". The FDA issued a decision of Substantially Equivalent on June 23, 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. The Kendal Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 23, 1989
Date Received
April 10, 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 The Kendal Co.

  • K000087 — MARHUKAR TRIPLE LUMEN CATHETER, MODEL 12 FR (March 17, 2000)
  • K990500 — KENDALL ULTRAMER COUDE FOLEY CATHETER, MODEL 1416C, KENDALL CURITY COUDE FOLEY C (September 28, 1999)
  • K991758 — MONOJECT INSULIN SYRINGE (June 14, 1999)
  • K970969 — KENDALL CURITY SUPRAPUBIC CATHETER TRAY, KIT, & REPLACEMENT SET (April 23, 1997)
  • K951488 — KENDALL CURITY CATHETER PLUG WITH PROTECTIVE CAP (April 25, 1995)
  • K942664 — KENDALL MODEL 6325 SCD SEQUEL COMPRESSION SYSTEM (January 17, 1995)
  • K942774 — POLYSKIN(R) M.R. MOIST RESPONSIVE TRANSPARENT DRESSING (July 20, 1994)
  • K892434 — KENDALL CURITY OXYGEN MASK (August 15, 1989)
  • K892440 — KENDALL CURITY EXTENSION TUBES (July 24, 1989)
  • K892438 — KENDALL CURITY INTRAVASCULAR CUT DOWN TUBES (July 24, 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