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510(k) K831796

URINE BAG SYSTEM by I M, Inc. — Product Code KNX

K831796 is an FDA 510(k) premarket notification submitted by I M, Inc. for the device "URINE BAG SYSTEM". The FDA issued a decision of Substantially Equivalent on August 8, 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. I M, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 8, 1983
Date Received
June 3, 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 I M, Inc.

  • K914600 — NEUROLOGICAL SPONGE (December 30, 1992)
  • K892389 — BIOPSY KIT (July 17, 1989)
  • K881363 — SYRINGE PREFILLED WITH WATER (June 23, 1988)
  • K880753 — UMBILICAL CORD CLAMP (April 27, 1988)
  • K872741 — NUTRIPUMP (October 20, 1987)
  • K871495 — BANDAGES CATALOG NUMBER: 101 TO 220 (May 8, 1987)
  • K863785 — MAKLER CATHETER (December 11, 1986)
  • K854155 — STERILE SALINE SOLUTION (December 10, 1985)
  • K853287 — HUBOUT (October 17, 1985)
  • K853288 — FEEDING UNITS & TUBES (October 4, 1985)

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