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510(k) K053361

MODIFICATION TO: MINIMESH POLYPROPYLENE MESH by Mpathy Medical Devices, Ltd. — Product Code OTO

K053361 is an FDA 510(k) premarket notification submitted by Mpathy Medical Devices, Ltd. for the device "MODIFICATION TO: MINIMESH POLYPROPYLENE MESH". The FDA issued a decision of Substantially Equivalent on February 6, 2006. The device falls under product code OTO (Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed), a Class II device regulated under 21 CFR 878.3300. Mpathy Medical Devices, Ltd. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 6, 2006
Date Received
December 2, 2005
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed
Device Class
Class II
Regulation Number
878.3300
Review Panel
OB
Submission Type

Bridging material to attach the vaginal apex to the anterior longitudinal ligament of the sacrum; Procedures include abdominal sacrocolpopexy and laparoscopic sacrocolpopexy.

Other clearances by Mpathy Medical Devices, Ltd.

  • K092203 — OMNISURE URETHRAL SLING, MODEL OTK52 (August 12, 2009)
  • K092207 — RESTORELLE POLYPROPYLENE MESH (August 4, 2009)
  • K091180 — MINITAPE URETHRAL SLING (July 14, 2009)
  • K073647 — MINITAPE EXTRA URETHRAL SLING (March 3, 2008)
  • K073646 — MINITAPE URETHRAL SLING (February 25, 2008)
  • K041632 — MINIMESH POLYPROPYLENE MESH (November 17, 2004)

Other clearances for product code OTO

  • K171271 — Polyform Synthetic Mesh (December 15, 2017)
  • K150016 — Vertessa Lite (April 6, 2015)
  • K150023 — Vertessa Lite Y-Mesh (April 6, 2015)
  • K140116 — RESTORELLE Y CONTOUR MESH (February 12, 2014)
  • K132061 — RESTORELLE M, RESTORELLE XL (August 2, 2013)
  • K123028 — VERTESSA LITE 10 X20CM, VERTESSA LITE 11 X 30CM, VERTESSA LITE Y-MESH (April 25, 2013)
  • K123914 — RESTORELLE Y CONTOUR (March 5, 2013)
  • K123337 — VERTESSA LITE 10 X 20CM, VERTESSA LITE 11 X 30CM (February 21, 2013)
  • K122968 — NOVASILK MESH QTY 1 MODEL 93-6014, NOVASILK MESH QTY 3 MODEL 93-6015 (December 18, 2012)
  • K122794 — UPSYLON Y MESH (December 18, 2012)

FDA data resources