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510(k) K253295

Coude Sleeved IC; Coude Plus Sleeved IC by Hollister Incorporated — Product Code EZD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 18, 2026
Date Received
September 29, 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 Hollister Incorporated

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  • K233524 — Sleeved IC 2 Family; Sleeved IC 2 SWT (Name not Finalized); Sleeved IC 2 Plus (N (May 3, 2024)
  • K220667 — Sleeved IC (December 8, 2022)
  • K213575 — Female IC (Not Finalized) (September 13, 2022)
  • K211436 — Intermittent Catheter (Not Finalized) (January 27, 2022)
  • K193148 — VaPro Plus Pocket, VaPro Plus (December 13, 2019)
  • K191633 — Infyna Chic (July 19, 2019)
  • K183253 — ValPro 2 Plus, VaPro 2 Plus Pocket (December 18, 2018)
  • K180824 — VaPro 2 Intermittent Catheter (June 22, 2018)
  • K163179 — Onli Intermittent Catheter (January 26, 2017)

Other clearances for product code EZD

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  • 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)