Cleared Traditional

GMD UNIVERSAL SLING, MODEL PRODUCT CODE 1010 AND 1020 (K083471) - FDA 510(k) Clearance

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

K083471 · Generic Medical Device, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2009
Decision
99d
Days
Class 2
Risk

K083471 is an FDA 510(k) clearance for the GMD UNIVERSAL SLING, MODEL PRODUCT CODE 1010 AND 1020. 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. (Gig Harbor, US). The FDA issued a Cleared decision on March 3, 2009 after a review of 99 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Generic Medical Device, Inc. devices

Submission Details

510(k) Number K083471 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 2008
Decision Date March 03, 2009
Days to Decision 99 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
31d faster than avg
Panel avg: 130d · This submission: 99d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 64
Devices cleared under the same product code (OTN) and FDA review panel - the closest regulatory comparables to K083471.
Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System
K231549 · Boston Scientific Corporation · Jun 2023
ArcSP Suprapubic Sling System
K222293 · Urocure, LLC · Sep 2022
ArcTO Transobturator Sling System
K222468 · Urocure, LLC · Sep 2022
Desara TV EZ 3.0 System, Desara Blue TV EZ 3.0 System, Desara TV EZ 2.7 System, Desara Blue TV EZ 2.7 System
K211975 · Caldera Medical, Inc. · Nov 2021
Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System
K211223 · Boston Scientific Corporation · Jul 2021
Athena Surgical RMUS System
K210087 · Athena Surgical, LLC · Apr 2021