510(k) K092207

RESTORELLE POLYPROPYLENE MESH by Mpathy Medical Devices, Inc. — Product Code OTP

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: August 4, 2009
Date Received: July 22, 2009
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 Mpathy Medical Devices, Inc.

K092203 — OMNISURE URETHRAL SLING, MODEL OTK52 (August 12, 2009)
K091180 — MINITAPE URETHRAL SLING (July 14, 2009)
K073647 — MINITAPE EXTRA URETHRAL SLING (March 3, 2008)
K073646 — MINITAPE URETHRAL SLING (February 25, 2008)
K053361 — MODIFICATION TO: MINIMESH POLYPROPYLENE MESH (February 6, 2006)
K041632 — MINIMESH POLYPROPYLENE MESH (November 17, 2004)

Other clearances for product code OTP

K122459 — PINNACLE LITE PELVIC FLOOR REPAIR KIT, POSTERIOR UPHOLD LITE VAGINAL SUPPORT SYS (December 13, 2012)
K121612 — ELEVATE PROLAPSE REPAIR SYSTEMS-APICAL NEEDLE PASSER SHEATH MODIFICATION (July 20, 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)
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)