Cleared Traditional

K242960 - AdVance™ XP Male Sling System (720163-03) (FDA 510(k) Clearance)

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

K242960 · Boston Scientific Corporation · Gastroenterology & Urology device
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Nov 2024
Decision
51d
Days
Class 2
Risk

K242960 is an FDA 510(k) clearance for the AdVance™ XP Male Sling System (720163-03). Classified as Mesh, Surgical, For Stress Urinary Incontinence, Male (product code OTM), Class II - Special Controls.

Submitted by Boston Scientific Corporation (Marlboro, US). The FDA issued a Cleared decision on November 15, 2024 after a review of 51 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Boston Scientific Corporation devices

Submission Details

510(k) Number K242960 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 2024
Decision Date November 15, 2024
Days to Decision 51 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
79d faster than avg
Panel avg: 130d · This submission: 51d
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.