Home / 510(k) Clearances / K223821

510(k) K223821

Self-Cath Closed System by Coloplast — Product Code FCM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 2, 2023
Date Received
December 21, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)
Device Class
Class II
Regulation Number
876.5130
Review Panel
GU
Submission Type

Other clearances by Coloplast

  • K252140 — Heylo™ System (October 6, 2025)
  • K251116 — Luja Coudé (June 27, 2025)
  • K250270 — Luja Set (April 17, 2025)
  • K242049 — SureCath Set (November 26, 2024)
  • K241210 — Luja Coude (November 21, 2024)
  • K242173 — Retrace Ureteral Access Sheath (ASXL10, ASXL12, ACXL10, ACXL12, AXXL10, AXXL12, (November 12, 2024)
  • K242473 — Altis Single Incision Sling System (519650); Aris Transobturator Sling System (5 (October 18, 2024)
  • K241028 — Luja female (20051); Luja female (20052); Luja female (20054); Luja female (2005 (July 26, 2024)
  • K233411 — Folysil Silicone Catheter (April 15, 2024)
  • K231953 — Biatain Fiber Ag (33570 - 5 cm x 5 cm / 2 in x 2 in); Biatain Fiber Ag (33572 - (March 22, 2024)

Other clearances for product code FCM

  • K250891 — Cure Catheter Insertion Kit (K1); Cure Catheter Insertion Kit (K2); Cure Cathete (June 6, 2025)
  • K082831 — AMSELF CLOSED CATHETERIZATION SYSTEM (October 23, 2008)
  • K070939 — SELF-CATH CS CLOSED URINARY CATHETERIZATION SYSTEM (June 1, 2007)
  • K070048 — GUARDIAN CATHETER-INFANT URINARY COLLECTION KIT (March 15, 2007)
  • K030712 — AMSURE URETHRAL CATHETERIZATION TRAY (May 23, 2003)
  • K030664 — AMSURE FOLEY INSERTION TRAY (May 23, 2003)
  • K011055 — THE O'NEIL STERILE FIELD URINARY CATHETER KIT WITH PREP PADS (June 6, 2001)
  • K010420 — RUSCH MMG/O'NEIL CATHETER (May 9, 2001)
  • K003873 — MENTOR SELF-CATH CLOSED SYSTEM (March 29, 2001)
  • K002803 — THE O'NEIL STERILE FIELD URINARY CATHETER KIT (December 27, 2000)