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    Tool · 510(k)

    510(k) Predicate Finder

    Find potential predicate devices for your 510(k) submission. Enter a K-number to find all clearances with the same product code, a three-letter product code to browse clearances directly, or search by device name.

    Product Code: OTN FDA class 2

    Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator

    General, Plastic Surgery

    View full classification →

    The Mesh, Surgical, Synthetic, Urogynecologic, for Stress Urinary Incontinence, Retropubic or Transobturator (product code OTN) is an implantable synthetic mesh used for the surgical treatment of female stress urinary incontinence due to intrinsic sphincter deficiency and/or urethral hypermobility. It is placed via retropubic or transobturator approaches to provide a mid-urethral sling. As an FDA Class 2 device under regulation 878.3300, it requires 510(k) premarket clearance and falls within the General and Plastic Surgery specialty, reviewed by the Urology panel. The device is flagged as an implant and is not life-sustaining.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System
    ArcSP Suprapubic Sling System
    ArcTO Transobturator Sling System
    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
    Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System
    Athena Surgical RMUS System
    GYNECARE TVT™ System, GYNECARE TVT™ with Abdominal Guides System, GYNECARE TVT™ Introducer and Catheter Guide, GYNECARE TVT EXACT™ Continence System and Trocar, GYNECARE TVT™ Obturator System and Passers and Winged Guide, GYNECARE TVT ABBREVO™ Continence System and Passers and Winged Guide
    ArcTV Transvaginal Sling System
    Desara TV, Desara Blue TV
    DESARA BLUE OV, DESARA BLUE SS
    SPARC SYSTEM AND MONARC, MONARC, AND MONARC C SYSTEMS
    RETROARC RETROPUBIC SLING SYSTEM
    DESARA MESH, DESARA BLUE
    GYNECARE TVT EXACT CONTINENCE SYSTEM
    DESARA SL
    BLUE SUI SLING
    KIM
    DESARA MESH
    GMD UNIVERSAL URINARY INCONTINENCE SLING
    SUPRIS RETROPUBIC SLING SYSTEM
    GYNECARE TVT ABBREVO CONTINENCE SYSTEM
    GMD UNIVERSAL URINARY INCONTINENCE SLING, MODEL 1012
    DESARA MESH MODEL: CAL-DS01
    ALIGN AND ALIGN TO URETHRAL SUPPORT SYSTEMS
    GYNECARE TVT EXACT CONTINENCE SYSTEM
    OMNISURE URETHRAL SLING, MODEL OTK52
    GMD UNIVERSAL SLING, MODEL PRODUCT CODE 1010 AND 1020
    SPARC SYSTEM / MONARC, MONARC C, MONARC + SYSTEMS
    DESARA MESH SLING, MODEL CAL-DS01
    MINITAPE EXTRA URETHRAL SLING
    ALIGN URETHRAL SUPPORT SYSTEM
    AMS SMART SLING SYSTEM
    T-SLING
    MENTOR ARIS SUPRAPUBIC SURGICAL KIT
    I-STOP MID-URETHRAL SLING, MODELS IS-1000, IS-2000, IS-3000, IS-4000
    I-STOP
    MONARC + SUBFASCIAL HAMMOCK, MODEL 72404193; MONARC C SUBFASCIAL HAMMOCK, MODEL 72404195.
    MENTOR ARIS TRANS-OBTURATOR TAPE AND SURGICAL KIT
    INTEMESH SILICONE-COATED SLING AND SURGICAL MESH WITH INHIBIZONE, MODEL 72403304
    MENTOR OBTAPE TRANS-OBTURATOR SURGICAL KIT
    SPARC, MONARC, BIOARC SP AND BIOARC TO SLING SYSTEMS
    URETEX TO TRANS-OBTURATOR URETHRAL SUPPORT SYSTEM
    MODIFICATION TO SURGICAL MESH POLYMERIC
    BIOARC SP SLING KIT AND BIOARC TO SLING KIT, MODELS 72403851, 72403996
    REMEEX SYSTEM FOR URINARY INCONTINENCE
    SAFYRE VS AND SAFYRE T
    GYNECARE TVT OBTURATOR SYSTEM
    MENTOR OBTAPE TRANS-OBTURATOR TAPE
    BIOARC SP SLING KIT
    MONARC SLING SYSTEM

    What is a Predicate Device?

    A predicate device is a legally marketed device that a new 510(k) applicant uses to demonstrate substantial equivalence. The FDA's 510(k) pathway requires manufacturers to show that their device has the same intended use and similar technological characteristics as one or more predicate devices already cleared for commercial distribution.

    Finding the right predicate is a critical step in 510(k) strategy. Manufacturers typically search for cleared devices with the same FDA product code, which groups devices by their intended use and regulatory classification. This tool helps you identify potential predicates by browsing all clearances within a product code.

    Note that predicate devices must be legally marketed — they cannot be devices that were cleared but never commercialized, or devices subject to a mandatory recall. The determination of substantial equivalence considers intended use, technological characteristics, and performance data.

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