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510(k) K072539

CURE CATHETER by Cure Medical, LLC — Product Code EZD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 13, 2007
Date Received
September 10, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

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

Other clearances by Cure Medical, LLC

  • K132500 — CURE CATHETER FEMALE, CURE CATHETER MALE, CURE CATHETER COUDE, CURE CATHETER PED (December 23, 2013)
  • K110653 — CURE CATHETER (August 1, 2011)
  • K080881 — CURE CATHETER CLOSED SYSTEM (June 11, 2008)

Other clearances for product code EZD

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  • 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)