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510(k) K131229

SPARC SYSTEM AND MONARC, MONARC, AND MONARC C SYSTEMS by American Medical Systems — Product Code OTN

K131229 is an FDA 510(k) premarket notification submitted by American Medical Systems for the device "SPARC SYSTEM AND MONARC, MONARC, AND MONARC C SYSTEMS". The FDA issued a decision of Substantially Equivalent on December 5, 2013. The device falls under product code OTN (Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator), a Class II device regulated under 21 CFR 878.3300. American Medical Systems has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 5, 2013
Date Received
April 30, 2013
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
Device Class
Class II
Regulation Number
878.3300
Review Panel
GU
Submission Type

Surgical treatment of female stress urinary incontinence due to intrinsic sphincter deficiency (isd) and/or urethral hypermobility

Other clearances by American Medical Systems

  • K140679 — SUREFLEX LITHOTRIPSY LASER FIBERS (June 20, 2014)
  • 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)
  • K100807 — MINIARC PRECISE SINGLE-INCISION SLING SYSTEM MODEL: 720181, 720191 (June 7, 2010)

Other clearances for product code OTN

  • K231549 — Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System (June 29, 2023)
  • K222293 — ArcSP Suprapubic Sling System (September 21, 2022)
  • K222468 — ArcTO Transobturator Sling System (September 15, 2022)
  • K211975 — Desara TV EZ 3.0 System, Desara Blue TV EZ 3.0 System, Desara TV EZ 2.7 System, (November 10, 2021)
  • K211223 — Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System (July 21, 2021)
  • K210087 — Athena Surgical RMUS System (April 12, 2021)
  • K201686 — GYNECARE TVT™ System, GYNECARE TVT™ with Abdominal Guides System, GYNECARE TVT™ (September 17, 2020)
  • K183134 — ArcTV Transvaginal Sling System (February 7, 2019)
  • K162201 — Desara TV, Desara Blue TV (January 11, 2017)
  • K140843 — DESARA BLUE OV, DESARA BLUE SS (July 1, 2014)

FDA data resources