510(k) K041632

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

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: November 17, 2004
Date Received: June 16, 2004
Clearance Type: Traditional
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)
K053361 — MODIFICATION TO: MINIMESH POLYPROPYLENE MESH (February 6, 2006)

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)
K122794 — UPSYLON Y MESH (December 18, 2012)
K122968 — NOVASILK MESH QTY 1 MODEL 93-6014, NOVASILK MESH QTY 3 MODEL 93-6015 (December 18, 2012)