Home / 510(k) Clearances / K172565

510(k) K172565

Advantage/Advantage Fit Delivery Device, Lynx Delivery Device, Obtryx Delivery Device (Curved & Halo), Obtryx II Delivery Device (Curved & Halo), Solyx SIS Delivery Device by Boston Scientific Corporation — Product Code PWJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 20, 2017
Date Received
August 25, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence
Device Class
Class II
Regulation Number
884.4910
Review Panel
GU
Submission Type

Used to aid in insertion, placement, fixation, or anchoring of surgical mesh for stress urinary incontinence

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 PWJ

  • K181151 — GYNECARE TVT Abbrevo Continence System; GYNECARE TVT Obturator Continence System (August 10, 2018)
  • K173019 — GYNECARE TVT Reusable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide, GY (July 6, 2018)
  • K173162 — GYNECARE TVT Abdominal Guides and Couplers, GYNECARE TVT Reuseable Introducer, G (June 28, 2018)
  • K172614 — Caldera Medical Transobturator Helical Introducer, Left; Caldera Medical Transob (May 4, 2018)