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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: GAW FDA class 2

    Suture, Nonabsorbable, Synthetic, Polypropylene

    General, Plastic Surgery

    View full classification →

    The Suture, Nonabsorbable, Synthetic, Polypropylene (product code GAW) is a monofilament synthetic suture made from polypropylene, widely used in general and plastic surgery for skin closure, cardiovascular procedures, and applications requiring minimal tissue reactivity and long-term tensile strength. It is classified as FDA Class 2, which requires a 510(k) premarket notification. The device is regulated under 21 CFR 878.5010 in the General, Plastic Surgery specialty (SU). This device carries an implant designation, as it is threaded through living tissue during use.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Cypris eXact Suturing System
    Non absorbable Surgical Polypropylene Suture
    Vesseal
    DURAMESH Mesh Suture
    APTOS Threads – Polypropylene Surgical Sutures
    Deklene MAXX
    Silhouette Featherlift / Silhouette Lift
    REXLENE
    Aesculap Optilene Nonabsorbable Suture
    Gazelle Polypropylene Suture and Delivery Device
    Assut Filbloc Permanent Sutures
    Silhouette Featherlift
    NobleStitch EL
    Pledgeted COR-SUTURE QUICK LOAD
    MOPYLEN, RESOPREN, SILK, POLYESTER, NYLON, RESOLON, POLYAMIDE PSEUDO, STEEL
    Quill Polypropylene Knotless Tissue-Closure Device, Variable Loop Design
    EDWARDS LIFESCIENCES THRUPORT KNOTTING SYSTEM
    StitchKit
    AESCULAP OPTILENE NONABSORBABLE SUTURE
    PROLENE POLYPROPYLENE NONABSORBABLE SUTURE
    SHARPOINT POLYPROPYLENE SURGICAL SUTURE, LOOK POLYPROPYLENE SURGICAL SUTURE, QUILL POLYPROPYLENE KNOTLESS TISSUE-CLOSURE
    QUILL POLYPROPYLENE KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN
    NOBLESTITCH EL NOBLESTITCH MR NOBLESTITCH TA
    SRM-STITCH 8F SRM-STITCH 8F WITH GUIDEWIRE
    QUILL QUADRAHELIX TISSUE-CLOSURE DEVICE
    SUTURE PLACEMENT DEVICE AND ACCESSORIES, FLEXIBLE SUTURE PLACEMENT DEVICE AND ACCESSORIES, LSI R SERIES SUTURE PLACEME
    DIGITEX SUTURE DELIVERY SYSTEM, MODEL 52025, DIGITEX SUTURE CARTRIDGE (SIZE O), MODEL 52026, DIGITEX SUTURE CARTRIDGE
    SUTRALENE POLYPROPYLENE SUTURES
    NEOTRACT ANCHOR
    KOLSTER METHODS, INC., FEATHERLIFT SILHOUETTE SUTURE
    SUPERSTITCH 5F, 12F, AND EL
    SUPERSTITCH GW, MODELS 06-15-04-GW, 08-15-04-GW
    COROLENE
    OPTIMIZED BARB DESIGN
    QUILL NONABSORBABLE POLYPROPYLENE BARBED SUTURE
    TRULENE NON-ABSORBABLE POLYPROPYLENE SURGICAL SUTURE
    MODIFICATION TO: MODIFIED USS POLYPROPYLENE SUTURE
    POLYPROPILENE SURGICAL SUTURES
    CONTOUR MIDFACE OPPOSING UNI-DIRECTIONAL THREADS
    CONTOUR NECKLIFT THREADS
    FEATHERLIFT EXTENDED APTOS THREAD
    CONTOUR FOREHEAD/BROWLIFT THREAD
    UNIPRO
    FEATHERLIFT EXTENDED LENGTH APTOS THREAD
    SUTURE FIXATION DEVICE; MESH FIXATION DEVICE
    SUPERSTITCH VASCULAR SUTURING DEVICE, 6 FRENCH, MODELS 06-15-00X; MID-LENGTH 06-25-00X
    SERRALENE, MODEL CATALOG NO 1S
    MODIFICATION TO: ABBOTT VASCULAR SUTURE ANASTOMOSIS DEVICE
    SUPERSTITCH VASCULAR SUTURING DEVICE
    AMS SLING FIXATION 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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