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510(k) K122968

NOVASILK MESH QTY 1 MODEL 93-6014, NOVASILK MESH QTY 3 MODEL 93-6015 by Coloplast Corp. — Product Code OTO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 18, 2012
Date Received
September 25, 2012
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.

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Other clearances for product code OTO

  • K171271 — Polyform Synthetic Mesh (December 15, 2017)
  • K150023 — Vertessa Lite Y-Mesh (April 6, 2015)
  • K150016 — Vertessa Lite (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)
  • K122440 — RESTORELLE L (November 19, 2012)