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510(k) K053371

AMS MALE TRANSOBTURATOR SLING SYSTEM by American Medical Systems, Inc. — Product Code OTM

K053371 is an FDA 510(k) premarket notification submitted by American Medical Systems, Inc. for the device "AMS MALE TRANSOBTURATOR SLING SYSTEM". The FDA issued a decision of Substantially Equivalent on February 3, 2006. The device falls under product code OTM (Mesh, Surgical, For Stress Urinary Incontinence, Male), a Class II device regulated under 21 CFR 878.3300. American Medical Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 3, 2006
Date Received
December 5, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mesh, Surgical, For Stress Urinary Incontinence, Male
Device Class
Class II
Regulation Number
878.3300
Review Panel
GU
Submission Type

surgical treatment of male stress urinary incontinence post-prostatectomy

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 OTM

  • K242960 — AdVance™ XP Male Sling System (720163-03) (November 15, 2024)
  • K231891 — Virtue Male Sling System with Alexis Wound Retractor Convenience Kit (September 25, 2023)
  • K211847 — AdVance XP Male Sling System (December 20, 2021)
  • K182169 — AdVance XP Male Sling (November 27, 2018)
  • K113496 — VIRTURE MALE SLING SYSTEM WITH ALEXIS WOUND RETRACTOR CONVENIENCE KIT (February 14, 2012)
  • K111881 — VIRTUE MALE SLING SYSTEM AND ALEXIS(R) WOUND RETRACTOR KIT (August 17, 2011)
  • K101297 — VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM MODEL 50020 (June 3, 2010)
  • K091152 — VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM, MODEL 50020 (May 7, 2009)
  • K082640 — VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM (October 17, 2008)
  • K063079 — I-STOP TRANS OBTURATOR MALE SLING (November 7, 2006)

FDA data resources