Cleared Special

Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System

K231549 · Boston Scientific Corporation · Gastroenterology & Urology

Jun 2023

Decision

30d

Days

Class 2

Risk

About This 510(k) Submission

K231549 is an FDA 510(k) clearance for the Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System, a Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator (Class II — Special Controls, product code OTN), submitted by Boston Scientific Corporation (Marborough, US). The FDA issued a Cleared decision on June 29, 2023, 30 days after receiving the submission on May 30, 2023. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 878.3300.

Submission Details

510(k) Number	K231549 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 30, 2023
Decision Date	June 29, 2023
Days to Decision	30 days
Submission Type	Special
Review Panel	Gastroenterology & Urology (GU)
Summary	Summary PDF

Device Classification

Product Code	OTN — Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 878.3300
Definition	Surgical Treatment Of Female Stress Urinary Incontinence Due To Intrinsic Sphincter Deficiency (isd) And/or Urethral Hypermobility