Cleared Traditional

K111219 - GMD UNIVERSAL URINARY INCONTINENCE SLING

K111219 is an FDA 510(k) clearance for GMD UNIVERSAL URINARY INCONTINENCE SLING, manufactured by Generic Medical Device, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code OTN cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K111219 · Generic Medical Device, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2011
Decision
59d
Days
Class 2
Risk

K111219 is an FDA 510(k) clearance for the GMD UNIVERSAL URINARY INCONTINENCE SLING. Classified as Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator (product code OTN), Class II - Special Controls.

Submitted by Generic Medical Device, Inc. (Ocean Shores, US). The FDA issued a Cleared decision on June 30, 2011 after a review of 59 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 Generic Medical Device, Inc. devices

FDA 510(k) Submission Details - K111219

510(k) Number K111219 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 2011
Decision Date June 30, 2011
Days to Decision 59 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
71d faster than avg
Panel avg: 130d · This submission: 59d
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 K111219.
RETROARC RETROPUBIC SLING SYSTEM
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GYNECARE TVT EXACT CONTINENCE SYSTEM
K132054 · Ethicon, Inc. · Aug 2013
BLUE SUI SLING
K121754 · Boston Scientific Corp · Oct 2012
SUPRIS RETROPUBIC SLING SYSTEM
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GYNECARE TVT ABBREVO CONTINENCE SYSTEM
K100936 · Ethicon, Inc. · Jul 2010
ALIGN AND ALIGN TO URETHRAL SUPPORT SYSTEMS
K093747 · C.R. Bard, Inc. · May 2010