Cleared Special

GMD UNIVERSAL URINARY INCONTINENCE SLING, MODEL 1012 (K101440) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K101440 · Generic Medical Devices, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2010
Decision
25d
Days
Class 2
Risk

K101440 is an FDA 510(k) clearance for the GMD UNIVERSAL URINARY INCONTINENCE SLING, MODEL 1012. Classified as Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator (product code OTN), Class II - Special Controls.

Submitted by Generic Medical Devices, Inc. (Ocean Shores, US). The FDA issued a Cleared decision on June 18, 2010 after a review of 25 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Generic Medical Devices, Inc. devices

Submission Details

510(k) Number K101440 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 24, 2010
Decision Date June 18, 2010
Days to Decision 25 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
105d faster than avg
Panel avg: 130d · This submission: 25d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 16
Devices cleared under the same product code (OTN) and FDA review panel - the closest regulatory comparables to K101440.
GYNECARE TVT EXACT CONTINENCE SYSTEM
K132054 · Ethicon, Inc. · Aug 2013
BLUE SUI SLING
K121754 · Boston Scientific Corp · Oct 2012
GYNECARE TVT ABBREVO CONTINENCE SYSTEM
K100936 · Ethicon, Inc. · Jul 2010
ALIGN AND ALIGN TO URETHRAL SUPPORT SYSTEMS
K093747 · C.R. Bard, Inc. · May 2010
GYNECARE TVT EXACT CONTINENCE SYSTEM
K100485 · Ethicon, Inc. · Mar 2010
ALIGN URETHRAL SUPPORT SYSTEM
K070073 · C.R. Bard, Inc. · Mar 2007