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510(k) K232665

GentleCath Air for Women (CH10); GentleCath Air for Women (CH12); GentleCath Air for Women (CH14) by Convatec — Product Code EZD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 25, 2024
Date Received
August 31, 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

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  • 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)