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510(k) K851471

TRIBAG, TRIBAND & TRIFIX-REUSEABLE URINE COLLECTOR by Lic-Orthion — Product Code KNX

K851471 is an FDA 510(k) premarket notification submitted by Lic-Orthion for the device "TRIBAG, TRIBAND & TRIFIX-REUSEABLE URINE COLLECTOR". The FDA issued a decision of Substantially Equivalent on Jun 12, 1985. The device falls under product code KNX (Collector, Urine, (And Accessories) For Indwelling Catheter), a Class II device regulated under 21 CFR 876.5250. Lic-Orthion has 16 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Jun 12, 1985
Date Received
Apr 15, 1985
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
510(k) Exempt

Other clearances by Lic-Orthion

  • K891649 — PATIENT EXAMINATION GLOVES (LATEX) (Apr 4, 1989)
  • K862022 — LIC-ORTHION MULTI-THERAPY TREATMENT TABLE (Jun 19, 1986)
  • K854730 — DAISY (ABSORBENT INCONTINENCE SHIELD) (Feb 6, 1986)
  • K854729 — ADAM (ABSORBENT INCONTINENCE SHIELD) (Feb 6, 1986)
  • K851470 — BIBAG, BIBAND & BIFIX - SINGLE USE URINE COLLECTOR (Jun 12, 1985)
  • K843234 — CITOMAT AUTOCLAVES (Oct 25, 1984)
  • K843233 — ANATOM SYSTEM (Oct 25, 1984)
  • K830853 — LAVATORY SEAT HEIGHTENER (Jun 8, 1983)
  • K830848 — RESI-WALKER (Apr 5, 1983)
  • K830851 — BATH TUB SEAT & BATH BOARD (Apr 5, 1983)

Other clearances for product code KNX

  • K110518 — IBAG (Jun 24, 2011)
  • K973364 — 4L DRAINAGE BAG, 4L BAG FOR PERITONEAL DIALYSIS, 4L URINARY DRAINAGE BAG (Mar 17, 1998)
  • K972887 — MEDLINE PREMIUM LEG BAG, MEDLINE FABRIC BAC LEG BAG, MEDLINE URINARY LEG BAG (Dec 11, 1997)
  • K971271 — BESECURE EXTERNAL URINARY COLLECTION SYSTEM (Aug 18, 1997)
  • K971929 — AMSINO URINARY LEG BAG (Aug 6, 1997)
  • K971764 — WELCON HUE-VU URINARY DRAINAGE BAG (Jul 29, 1997)
  • K964690 — LIBERTY VALVE (Mar 21, 1997)
  • K964745 — AMSINO URINARY DRAINAGE BAG (Mar 18, 1997)
  • K962652 — URINARY DRAINAGE BAG, (REORDER NO. 0749 - PRODUCT NO. 900-749) (Oct 4, 1996)
  • K960949 — PROSYS BEDSIDE DRAINAGE BAG (STERILE) MODEL 650167 (Apr 19, 1996)

FDA data resources