Cleared Traditional

K172565 - Advantage/Advantage Fit Delivery Device, Lynx Delivery Device, Obtryx Delivery Device (Curved & Halo), Obtryx II Delivery Device (Curved & Halo), Solyx SIS Delivery Device (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K172565 · Boston Scientific Corporation · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2017
Decision
117d
Days
Class 2
Risk

K172565 is an FDA 510(k) clearance for the Advantage/Advantage Fit Delivery Device, Lynx Delivery Device, Obtryx Deliver.... Classified as Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence (product code PWJ), Class II - Special Controls.

Submitted by Boston Scientific Corporation (Marlboro, US). The FDA issued a Cleared decision on December 20, 2017 after a review of 117 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 884.4910 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Boston Scientific Corporation devices

Submission Details

510(k) Number K172565 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
13d faster than avg
Panel avg: 130d · This submission: 117d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PWJ Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence
Device Class Class 2 - 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
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.