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510(k) K780837

URINARY DRAINAGE BAG by Intermed, Inc. — Product Code KNX

K780837 is an FDA 510(k) premarket notification submitted by Intermed, Inc. for the device "URINARY DRAINAGE BAG". The FDA issued a decision of Substantially Equivalent on July 27, 1978. The device falls under product code KNX (Collector, Urine, (And Accessories) For Indwelling Catheter), a Class II device regulated under 21 CFR 876.5250. Intermed, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 27, 1978
Date Received
May 23, 1978
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 Intermed, Inc.

  • K900857 — NON STERILE PARENTERAL SUPPLY KIT (May 22, 1990)
  • K842166 — INTERMED, INS STERILE WATER/SALINE (February 12, 1985)
  • K833126 — DRESSING CHANGE TRAYS (January 27, 1984)
  • K833574 — PERCUTANEOUS SHEATH INTRODUCER TRAYS (January 11, 1984)
  • K833573 — CENTRAL VEIN CATH. TRAY CC-20-1420 (January 11, 1984)
  • K833139 — ACUTE HEMODIALYSIS TRAYS (December 22, 1983)
  • K833059 — SUCTION CATHETER TRAYS (December 12, 1983)
  • K821269 — TRACHEOSTOMY CARE TRAYS (May 27, 1982)
  • K791427 — CATHETERIZATION TRAYS FOLEY AND URETHRAL (September 7, 1979)
  • K791426 — PERITONEAL PAC (August 28, 1979)

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