Cleared Traditional

Advantage/Advantage Fit Delivery Device, Lynx Delivery Device, Obtryx Delivery Device (Curved & Halo), Obtryx II Delivery Device (Curved & Halo), Solyx SIS Delivery Device

K172565 · Boston Scientific Corporation · Gastroenterology & Urology

Dec 2017

Decision

117d

Days

Class 2

Risk

About This 510(k) Submission

K172565 is an FDA 510(k) clearance for the Advantage/Advantage Fit Delivery Device, Lynx Delivery Device, Obtryx Delivery Device (Curved & Halo), Obtryx II Delivery Device (Curved & Halo), Solyx SIS Delivery Device, a Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence (Class II — Special Controls, product code PWJ), submitted by Boston Scientific Corporation (Marborough, US). The FDA issued a Cleared decision on December 20, 2017, 117 days after receiving the submission on August 25, 2017. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 884.4910.

Submission Details

510(k) Number	K172565 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 25, 2017
Decision Date	December 20, 2017
Days to Decision	117 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	Summary PDF

Device Classification

Product Code	PWJ — Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 884.4910
Definition	Used To Aid In Insertion, Placement, Fixation, Or Anchoring Of Surgical Mesh For Stress Urinary Incontinence