Home / 510(k) Clearances / K071902

510(k) K071902

AMS MINIARC SLING SYSTEM by American Medical Systems, Inc. — Product Code PAH

K071902 is an FDA 510(k) premarket notification submitted by American Medical Systems, Inc. for the device "AMS MINIARC SLING SYSTEM". The FDA issued a decision of Substantially Equivalent on August 24, 2007. The device falls under product code PAH (Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling), 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
August 24, 2007
Date Received
July 10, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling
Device Class
Class II
Regulation Number
878.3300
Review Panel
GU
Submission Type

Transvaginal surgical repair of female stress urinary incontinence (SUI) due to intrinsic sphincter deficiency (ISD) and/or urethral hypermobility.

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 PAH

  • K242473 — Altis Single Incision Sling System (519650); Aris Transobturator Sling System (5 (October 18, 2024)
  • K221874 — Altis Single Incision Sling System (February 15, 2023)
  • K191416 — Desara One Single Incision Sling System, 1 Pack ; Desara One Single Incision Sli (February 7, 2020)
  • K121562 — ALTIS SINGLE INCISION CLING SYSTEM (November 5, 2012)
  • K123179 — AJUST HELICAL ADJUSTABLE SINGLE-INCISION SLING (November 2, 2012)
  • K121641 — MINIARC PRO SINGLE-INCISION SLING SYSTEM (September 7, 2012)
  • K110420 — OPHIRA MINI SLING SYSTEM (May 8, 2012)
  • K103418 — DESARA MINI (November 30, 2011)
  • K100807 — MINIARC PRECISE SINGLE-INCISION SLING SYSTEM MODEL: 720181, 720191 (June 7, 2010)
  • K092607 — AJUST ADJUSTABLE SINGLE INCISION SLING (November 20, 2009)

FDA data resources