Cleared Traditional

K063079 - I-STOP TRANS OBTURATOR MALE SLING

K063079 is an FDA 510(k) clearance for I-STOP TRANS OBTURATOR MALE SLING, manufactured by Cl Medical. The device is a Class 2 Gastroenterology & Urology device with product code OTM cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K063079 · Cl Medical · Gastroenterology & Urology device
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Nov 2006
Decision
28d
Days
Class 2
Risk

K063079 is an FDA 510(k) clearance for the I-STOP TRANS OBTURATOR MALE SLING. Classified as Mesh, Surgical, For Stress Urinary Incontinence, Male (product code OTM), Class II - Special Controls.

Submitted by Cl Medical (Sainte Foy Les Lyon, FR). The FDA issued a Cleared decision on November 7, 2006 after a review of 28 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 Cl Medical devices

FDA 510(k) Submission Details - K063079

510(k) Number K063079 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 10, 2006
Decision Date November 07, 2006
Days to Decision 28 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
102d faster than avg
Panel avg: 130d · This submission: 28d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OTM Device Classification - Class 2, Special Controls

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 9
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