BEUDAMED
    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: GAR FDA class 2

    Suture, Nonabsorbable, Synthetic, Polyamide

    General, Plastic Surgery

    View full classification →

    The Suture, Nonabsorbable, Synthetic, Polyamide (product code GAR) is a synthetic, nonabsorbable suture made from polyamide (nylon), used for wound closure and tissue approximation in general and plastic surgery settings where a durable, non-degrading suture is required. It is classified as FDA Class 2, requiring a 510(k) premarket notification. The device is regulated under 21 CFR 878.5020 in the General, Plastic Surgery specialty (SU). This device carries an implant designation, as it is threaded through body tissue during use.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Tissue Approximation System (TAS)
    Golnit Nylon Monofilament Suture
    Non Absorbable Surgical Nylon Suture
    Crownjun Nylon Suture
    REXLON, REXSIL
    Aesculap Dafilon Nonabsorbable Polyamide Surgical Suture
    RiverLon (Nylon) Suture
    VITAL SUTURES SUTUREX CIRUGIA PERUANA SUTUMED
    KUMAR T-ANCHORS HERNIA SET
    FSSB NYLON SURGICAL SUTURES
    MANI NEEDLE & SUTURE PACK (NYLON)
    AESCULAP TRELON NONABSORBABLE MULTIFILAMENT POLYAMIDE SURGICAL SUTURE
    QUILL NONABSORBABLE NYLON BARBED SUTURE
    ARTELON SURGICAL SUTURE
    TRULON NON-ABSORBABLE POLYAMIDE SURGICAL SUTURE
    UNIMIDE
    NYLON THREADED NEEDLE
    ARTELON SURGICAL SUTURE
    S&T MICROSURGICAL SUTURE
    ORLON NONABSORABLE SURGICAL SUTURE USP
    DEMETECH NYLON NONABSORBABLE SUTURE
    NYLON SUTURE
    SERRALNYL
    GRAMS NYLON NONABSORBABLE SUTURE
    NYLON, NONABSORBABLE SURGICAL SUTURES USP
    NYLON NONABSORBABLE SURGICAL SUTURES, USP
    MICRINS MICROSURGICAL SUTURE
    SUTRALON NYLON SUTURES
    NYLON
    DAFILON NONABSORBABLE POLYAMIDE SURGICAL SUTURE
    SURGILON, DERMALON, & OPHTHALON
    CUTALON NYLON POLYAMIDE SURGICAL SUTURE
    NYLON NOABSORBABLE SURGICAL SUTURES USP
    SURGIDEK S
    SURGIDEK B
    SURGIDEK
    SUTURE NON-ABSORBABLE SYNTHETIC POLYLMIDE
    SUTURE ABSORBABLE- GUT
    LUKENS NYLON SURGICAL SUTURE
    NON-ABSORBABLE SURGICAL SUTURES
    SUPRAMID SUTURE
    NYLAMID SUTURE
    SILK SUTURES-REVISED LABELING
    REVISED LABELING FOR NYLON SUTURE (POLYAMIDE)
    DERMALON,SURGILON,OPHTHALON,& OPHTHALMIC NYLON SUT
    VISITEC MICROSURGICAL SUTURE
    URESIL LOCKING GENERAL PURPOSE DRAINAGE CATHETER
    PETERS CARDIONYL(TM) SUTURE
    N80-838 SUPRAMID EXTRA SUTURE
    ADVANCE SUTURE NONABSORBABLE NYLON 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.

    Popular Product Codes

    Commonly searched
    DQA Oximeter DTB Permanent Pacemaker Electrode DXN System, Measurement, Blood-Pressure, Non-Invasive LLZ System, Image Processing, Radiological MNR Ventilatory Effort Recorder NQK Maggots, Medical OEI Drainage Catheter With Antibiotic PIB Diabetic Retinopathy Detection Device QAS Radiological Computer-Assisted Triage And Notification Software QFG Alternate Controller Enabled Insulin Infusion Pump