Cleared Traditional

K182169 - AdVance XP Male Sling

K182169 is the FDA 510(k) clearance for AdVance XP Male Sling by Boston Scientific Corporation. It is a Class 2 Gastroenterology & Urology device (product code OTM) cleared through the Traditional 510(k) pathway after a 109-day FDA review.

K182169 · Boston Scientific Corporation · Gastroenterology & Urology device
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Nov 2018
Decision
109d
Days
Class 2
Risk

K182169 is an FDA 510(k) clearance for the AdVance XP Male Sling. Classified as Mesh, Surgical, For Stress Urinary Incontinence, Male (product code OTM), Class II - Special Controls.

Submitted by Boston Scientific Corporation (Minnetonka, US). The FDA issued a Cleared decision on November 27, 2018 after a review of 109 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 878.3300 - 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 K182169 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 2018
Decision Date November 27, 2018
Days to Decision 109 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
21d faster than avg
Panel avg: 130d · This submission: 109d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OTM Mesh, Surgical, For Stress Urinary Incontinence, Male
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.3300
Definition Surgical Treatment Of Male Stress Urinary Incontinence Post-prostatectomy
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.

Regulatory Peers - OTM Mesh, Surgical, For Stress Urinary Incontinence, Male

All 8
Devices cleared under the same product code (OTM) and FDA review panel - the closest regulatory comparables to K182169.
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