510(k) K121612

ELEVATE PROLAPSE REPAIR SYSTEMS-APICAL NEEDLE PASSER SHEATH MODIFICATION by American Medical Systems — Product Code OTP

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: July 20, 2012
Date Received: June 1, 2012
Clearance Type: Special
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed
Device Class: Class III
Regulation Number: 884.5980
Review Panel: OB
Submission Type

Tissue reinforcement of the fibromuscular layer of the pelvic floor when surgical treatment is indicated; Procedures include anterior and posterior vaginal wall prolapse repair and vaginal apical or uterine prolapse repair performed transvaginally

Other clearances by American Medical Systems

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)
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 OTP

K122459 — PINNACLE LITE PELVIC FLOOR REPAIR KIT, POSTERIOR UPHOLD LITE VAGINAL SUPPORT SYS (December 13, 2012)
K112842 — AMS ELEVATE PC (October 25, 2011)
K103426 — LITE PELVIC FLOOR REPAIR KITS (September 14, 2011)
K112386 — EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEM (September 8, 2011)
K102815 — SURELIFT PROLAPSE SYSTEM (July 7, 2011)
K111118 — AMS ELEVATE PC APICAL AND POSTERIOR ( AND ANTERIOR AND APICAL) PROLAPSE REPAIR S (July 1, 2011)
K092207 — RESTORELLE POLYPROPYLENE MESH (August 4, 2009)
K083499 — EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEMS (May 8, 2009)
K091131 — PELVIC FLOOR REPAIR SYSTEM (May 8, 2009)
K090713 — ELEVATE PROLAPSE REPAIR SYSTEM WITH PC COATED INTEPRO LITE- APICAL AND POSTERIOR (April 2, 2009)