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510(k) K191061

Optilume Basic Urological Balloon Dilation Catheter by Urotronic, Inc. — Product Code KOE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 2, 2020
Date Received
April 22, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dilator, Urethral
Device Class
Class II
Regulation Number
876.5520
Review Panel
GU
Submission Type

Other clearances by Urotronic, Inc.

  • K250910 — Optilume® High Pressure Urological Balloon Dilation Catheter (May 22, 2025)

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  • K961904 — AQ HYDROPHILIC DILATORS (October 18, 1996)
  • K924440 — U.S. MEDICAL PS-7000 DIALYSIS SCALE (May 26, 1993)
  • K920551 — 120 FR OPTILUME PROSTATE BALLOON DILATOR (October 28, 1992)
  • K922349 — DOWD(TM) II (August 14, 1992)
  • K920711 — ENTRAC URETHRAL BALLOON DILATATION CATHETER (May 6, 1992)
  • K913477 — APEX(TM) PROSTATIC BALLOON DILATION CATHETER (December 27, 1991)
  • K902585 — UROPLASTY TCU PROSTATIC URETHROPLASTY CATHETER (August 27, 1990)