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510(k) K230400

Cure Catheter Closed System; Cure Dextra Closed System by Convatec, Inc. — Product Code EZD

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
November 8, 2023
Date Received
February 15, 2023
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 Convatec, Inc.

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  • K221593 — Cure Ultra Male, Cure Ultra Female, Cure Ultra Plus (November 17, 2022)
  • K162906 — Flexi-Seal PROTECT Fecal Management System (March 7, 2017)
  • K150350 — Flexi-Seal Signal Fecal Management System (July 21, 2015)
  • K140953 — GENTLECATH MALE COUDE OLIVE TIP INTERMITTENT URINARY CATHETER (August 1, 2014)
  • K123481 — AQUACEL AG FOAM HYDROFIBER FOAM DRESSING WITH SILVER, ADHESIVE AND NON ADHESIVE (June 6, 2013)
  • K121275 — AQUACEL AG EXTRA HYDROFIBER DRESSING WITH SILVER AND STRENGTHENING FIBER (July 25, 2012)
  • K112342 — FLEXI-SEAL SIGNAL FECAL MANAGEMENT SYSTEM (April 26, 2012)

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)