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510(k) K250910

Optilume® High Pressure Urological Balloon Dilation Catheter by Urotronic, Inc. — Product Code EZN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 22, 2025
Date Received
March 26, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dilator, Catheter, Ureteral
Device Class
Class II
Regulation Number
876.5470
Review Panel
GU
Submission Type

Other clearances by Urotronic, Inc.

  • K191061 — Optilume Basic Urological Balloon Dilation Catheter (January 2, 2020)

Other clearances for product code EZN

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  • K201007 — In-Ka Ureteral Balloon Dilatation Catheter (June 11, 2020)
  • K190612 — EQUINOX Balloon Dilatation Catheter (December 6, 2019)
  • K173654 — Ureteral Dilator Sets, Ureteral Dilators (July 17, 2018)
  • K180756 — Safety Wire Guide Introducer (May 24, 2018)
  • K180028 — Cook 810 Set, Desilets-Hoffman Introducer Set (May 2, 2018)
  • K172588 — Balloon Catheter and Balloon Ureteral Dilator Set (April 19, 2018)
  • K170531 — Ureteral Dilators and Percutaneous Nephrostomy Dilators (August 17, 2017)
  • K132181 — GYRUS ACMI URO-EZDILATE URETERAL BALLOON DILATION CATHETER (October 21, 2013)
  • K130804 — UROMAX ULTRA BALLOON DILATATION CATHETER (May 22, 2013)