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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: GAM FDA class 2

    Suture, Absorbable, Synthetic, Polyglycolic Acid

    General, Plastic Surgery

    View full classification →

    The Suture, Absorbable, Synthetic, Polyglycolic Acid (product code GAM) is a synthetic absorbable suture made from polyglycolic acid, which is broken down by hydrolysis in the body over weeks to months, used for internal tissue closure during general and plastic surgery. It is classified as FDA Class 2, indicating moderate risk, and requires a 510(k) premarket notification. The device is regulated under 21 CFR 878.4493 in the General, Plastic Surgery specialty (SU). This device carries an implant designation, as it is placed within body tissue during use.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Trexon™ Monofilament Synthetic Absorbable Suture
    MONOCRYL™ Plus Antibacterial Poliglecaprone – 25 (Monofilament), Sterile Synthetic Absorbable Surgical Suture
    STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device; STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Device
    TroClose 1200
    PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Calypso); PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Odysseus)
    Monotime and Optime R
    Peters Surgical ADVANTIME Absorbable Suture (ADVANTIME)
    StitchKit
    STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Device
    MONOFIX PGCL, knotless wound closure device
    StitchKit
    StitchKit COMBO
    Monocryl Plus Antibacterial Suture
    REXSIN
    Silhouette Instalift
    STRATAFIX Spiral Monocryl, Plus Bidirectional Knotless Tissue Control Device
    VICRYL Polyglactin 910 Sterile Synthetic Absorbable Surgical Suture, PDS II Polydioxanone Sterile Synthetic Absorbable Surgical Suture, PDS Plus Antibacterial Polydioxanone Sterile Synthetic Absorbable Surgical Suture
    WEGO-PGLA RAPID
    WEGO-PGA RAPID
    Coated Vicryl Plus Antibacterial (Polyglactin 910) Absorable Suture
    Caprolon
    Rondek PGA Suture (Beige or Violet)
    StitchKit V-Loc 90, StitchKit V-Loc 180, StitchKit Quill PDO
    REXMONO, PDREX
    Holycon Synthetic Absorbable Sutures
    Monosyn Quick Synthetic Absorbable Surgical Suture
    CARESORB-Polyglactin 910 Surgical Suture, CARESORB-Polyglactin 910 (fast absorbing) Surgical Suture
    MEGASORB - Natural absorbable Polyglycolic Acid Surgical Suture, MITSU - Absorbable Polyglactin 910 Surgical Sutures, MITSU FST - Absorbable Polyglactin 910 Surgical Suture, FILAXYN - Absorbable Polydioxanone Surgical (PDS), FILAPRON - Absorbable poly(glycolide-co-caprolactone) Surgical Suture
    Silhouette InstaLift
    TroClose1200, TroClose1200 Cannula
    Novosyn Quick Absorbable Suture
    CRYLREX
    TroClose1200
    E-Pack Procedure Kit
    Coated VICRYU (Polyglactin 91O)Sterile Synthetic Absorbable Suture Cartridges, ETHIBOND Polybutilate Coated Polyester Sterile Synthetic Non-Absorbable Suture Cartridges, PROXISURE Suturing Device
    PGA RESORBA, PGA RESOQUICK, GLYCOLON
    Megasorb, Mitsu, Mitsu FST, Filaxyn, Filapron
    STRATAFIX Spiral MONOCRYL Knotless Tissue Control Device, STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device
    SILHOUETTE INSTALIFT
    PLIASURE Polyglycolide Synthetic Absorbable Suture
    WEGO-PGCL Absorbable Surgical Monofilament Suture
    POLYCRYL
    QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN
    POLYSYN SURGICAL SUTURE
    QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE
    DEMEQUICKTM (RAPID ABSORBABLE) SYNTHETIC SURGICAL SUTURE
    MONODERM SURGICAL SUTURE
    COATED VICRYL PLUS ANTIMICROBIAL (POLYGLACTIN 910) SYNTHETIC ABSORBABLE SUTURE
    SYNTHETIC ABSORBABLE SUTURE
    SYNTHETIC ABSORBABLE SUTURE

    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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