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510(k) K252943

GentleCath Air for Men; GentleCath Glide Intermittent Catheter; GentleCath Air for Women by Convatec Limited — Product Code EZD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 1, 2026
Date Received
September 15, 2025
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 Limited

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  • K180205 — AVELLE Negative Pressure Wound Therapy System (October 19, 2018)
  • K181206 — GentleCath Glide Intermittent Urinary Catheter (August 16, 2018)
  • K173675 — AQUACEL Ag+ EXTRA Enhanced Hydrofiber Dressing with Silver and Strengthening Fib (July 20, 2018)
  • K172924 — GentleCath Intermittent Urinary Catheter (November 21, 2017)
  • K161344 — GentleCath Glide Intermittent Catheter (September 20, 2016)
  • K152926 — AQUACEL Ag Surgical SP Dressing (January 21, 2016)

Other clearances for product code EZD

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  • 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)