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510(k) K241028

Luja female (20051); Luja female (20052); Luja female (20054); Luja female (20056) by Coloplast — Product Code EZD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 26, 2024
Date Received
April 15, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Straight
Device Class
Class II
Regulation Number
876.5130
Review Panel
GU
Submission Type

Other clearances by Coloplast

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  • 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)
  • 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)
  • K233101 — Luja Coude (20108 Male CH18 - large packaging) (October 26, 2023)

Other clearances for product code EZD

  • K260502 — Liv Pre-lubricated Intermittent Catheter (March 12, 2026)
  • K251274 — EZ-Protect Hydrophilic Closed System Intermittent Catheter; EZ-Protect Hydrophil (January 29, 2026)
  • K251178 — Ready to use Nelaton Catheter (January 2, 2026)
  • K251468 — Sleeved IC 3 Family Sleeved IC 3 SWT (name not finalized) Sleeved IC 3 Pocket (n (October 3, 2025)
  • K250659 — LoFric Origo (September 26, 2025)
  • K250699 — Cure Twist Female 8 Catheter (T8); Cure Twist Female 10 Catheter (T10); Cure Twi (July 1, 2025)
  • K251116 — Luja Coudé (June 27, 2025)
  • K243175 — Disposable Intermittent Catheter (TPU Catheter) (June 26, 2025)
  • K250270 — Luja Set (April 17, 2025)
  • K242049 — SureCath Set (November 26, 2024)