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510(k) K092207

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

K092207 is an FDA 510(k) premarket notification submitted by Mpathy Medical Devices, Inc. for the device "RESTORELLE POLYPROPYLENE MESH". The FDA issued a decision of Substantially Equivalent on August 4, 2009. The device falls under product code OTP (Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed), a Class III device regulated under 21 CFR 884.5980. Mpathy Medical Devices, Inc. has at least 6 other 510(k) clearances on record.

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)
  • K091131 — PELVIC FLOOR REPAIR SYSTEM (May 8, 2009)
  • K083499 — EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEMS (May 8, 2009)
  • K090713 — ELEVATE PROLAPSE REPAIR SYSTEM WITH PC COATED INTEPRO LITE- APICAL AND POSTERIOR (April 2, 2009)

FDA data resources