Home / 510(k) Clearances / K211223

510(k) K211223

Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System by Boston Scientific Corporation — Product Code OTN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 21, 2021
Date Received
April 23, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
Device Class
Class II
Regulation Number
878.3300
Review Panel
GU
Submission Type

Surgical treatment of female stress urinary incontinence due to intrinsic sphincter deficiency (isd) and/or urethral hypermobility

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 OTN

  • K231549 — Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System (June 29, 2023)
  • K222293 — ArcSP Suprapubic Sling System (September 21, 2022)
  • K222468 — ArcTO Transobturator Sling System (September 15, 2022)
  • K211975 — Desara TV EZ 3.0 System, Desara Blue TV EZ 3.0 System, Desara TV EZ 2.7 System, (November 10, 2021)
  • K210087 — Athena Surgical RMUS System (April 12, 2021)
  • K201686 — GYNECARE TVT™ System, GYNECARE TVT™ with Abdominal Guides System, GYNECARE TVT™ (September 17, 2020)
  • K183134 — ArcTV Transvaginal Sling System (February 7, 2019)
  • K162201 — Desara TV, Desara Blue TV (January 11, 2017)
  • K140843 — DESARA BLUE OV, DESARA BLUE SS (July 1, 2014)
  • K131229 — SPARC SYSTEM AND MONARC, MONARC, AND MONARC C SYSTEMS (December 5, 2013)