Home / 510(k) Clearances / K171271

510(k) K171271

Polyform Synthetic Mesh by Boston Scientific Corporation — Product Code OTO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 15, 2017
Date Received
May 1, 2017
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 Boston Scientific Corporation

  • K260479 — TheraSphere 360™ Y-90 Management Platform (March 13, 2026)
  • K260119 — SpaceOAR Vue System (SV-2101) (February 10, 2026)
  • K253376 — OBSIDIO™ Conformable Embolic (M0013972101010) (October 30, 2025)
  • K252529 — Moses™ 200 D/F/L Laser Fiber (M0068130100); Moses™ 365 D/F/L Laser Fiber (M00681 (October 30, 2025)
  • K252547 — TheraSphere 360™ Y-90 Management Platform (October 28, 2025)
  • K252921 — Radial Jaw 4 Pulmonary Biopsy Forceps (September 26, 2025)
  • K252703 — LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard with pressure (September 24, 2025)
  • K252593 — LUX-Dx II Insertable Cardiac Monitor (M302); LUX-Dx II+ Insertable Cardiac Monit (September 12, 2025)
  • K251759 — Flexiva Pulse Laser Fiber; Flexiva Pulse TracTip Laser Fiber; Flexiva Pulse ID L (July 9, 2025)
  • K250310 — VIKING™ Fixed Curve Diagnostic Catheter (June 27, 2025)

Other clearances for product code OTO

  • 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)
  • K122440 — RESTORELLE L (November 19, 2012)