Cleared Traditional

K050148 - MENTOR ARIS TRANS-OBTURATOR TAPE AND SU...

K050148 is an FDA 510(k) clearance for MENTOR ARIS TRANS-OBTURATOR TAPE AND SU..., manufactured by Mentor Corporation. The device is a Class 2 Gastroenterology & Urology device with product code OTN cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K050148 · Mentor Corporation · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Mar 2005
Decision
44d
Days
Class 2
Risk

K050148 is an FDA 510(k) clearance for the MENTOR ARIS TRANS-OBTURATOR TAPE AND SURGICAL KIT. Classified as Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator (product code OTN), Class II - Special Controls.

Submitted by Mentor Corporation (Santa Barbara, US). The FDA issued a Cleared decision on March 9, 2005 after a review of 44 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 Mentor Corporation devices

FDA 510(k) Submission Details - K050148

510(k) Number K050148 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 24, 2005
Decision Date March 09, 2005
Days to Decision 44 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
86d faster than avg
Panel avg: 130d · This submission: 44d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OTN Device Classification - Class 2, Special Controls

Product Code OTN Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.3300
Definition Surgical Treatment Of Female Stress Urinary Incontinence Due To Intrinsic Sphincter Deficiency (isd) And/or Urethral Hypermobility
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 - OTN Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator

All 36
Devices cleared under the same product code (OTN) and FDA review panel - the closest regulatory comparables to K050148.
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