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510(k) K920551

120 FR OPTILUME PROSTATE BALLOON DILATOR by American Medical Systems, Inc. — Product Code KOE

K920551 is an FDA 510(k) premarket notification submitted by American Medical Systems, Inc. for the device "120 FR OPTILUME PROSTATE BALLOON DILATOR". The FDA issued a decision of Substantially Equivalent on October 28, 1992. The device falls under product code KOE (Dilator, Urethral), a Class II device regulated under 21 CFR 876.5520. American Medical Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 28, 1992
Date Received
February 6, 1992
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 American Medical Systems, Inc.

  • K140679 — SUREFLEX LITHOTRIPSY LASER FIBERS (June 20, 2014)
  • K131229 — SPARC SYSTEM AND MONARC, MONARC, AND MONARC C SYSTEMS (December 5, 2013)
  • K132655 — RETROARC RETROPUBIC SLING SYSTEM (November 20, 2013)
  • K121805 — AMS LARGE PORE POLYPROPHLENE MESH (October 16, 2012)
  • K121641 — MINIARC PRO SINGLE-INCISION SLING SYSTEM (September 7, 2012)
  • K121612 — ELEVATE PROLAPSE REPAIR SYSTEMS-APICAL NEEDLE PASSER SHEATH MODIFICATION (July 20, 2012)
  • K120870 — GREENLIGHT MOXY FIBER OPTIC (June 15, 2012)
  • K112842 — AMS ELEVATE PC (October 25, 2011)
  • K111118 — AMS ELEVATE PC APICAL AND POSTERIOR ( AND ANTERIOR AND APICAL) PROLAPSE REPAIR S (July 1, 2011)
  • K100746 — FIBER ONE (June 11, 2010)

Other clearances for product code KOE

  • K191061 — Optilume Basic Urological Balloon Dilation Catheter (January 2, 2020)
  • K032840 — ATRION MEDICAL QL INFLATION DEVICE (March 3, 2004)
  • K972964 — ATRION MEDICAL BALLOON CATHETER INFLATION DEVICE (October 10, 1997)
  • K962611 — BARD EAGLE INFLATION DEVICE (October 21, 1996)
  • K961904 — AQ HYDROPHILIC DILATORS (October 18, 1996)
  • K924440 — U.S. MEDICAL PS-7000 DIALYSIS SCALE (May 26, 1993)
  • 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)

FDA data resources