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: NEW FDA class 2

    Suture, Surgical, Absorbable, Polydioxanone

    General, Plastic Surgery

    View full classification →

    The Suture, Surgical, Absorbable, Polydioxanone (product code NEW) is a monofilament absorbable surgical suture made from polydioxanone polymer, used to close wounds and approximate tissue, where it is gradually absorbed by the body over time. It is classified as an FDA Class 2 device within the General and Plastic Surgery specialty, requiring 510(k) premarket clearance. No specific regulation number has been assigned to this product code. The device carries an implant designation as it is placed within the body, and it is not flagged as life-sustaining.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Suture-TOOL System
    Suture-TOOL System
    Secret Line up (FC1938E80 FC1950E90 FC1960E100 FC1970E120 FC1990E150 FC19100E150 FC19100E280 FC19100E420 FC2038E80 FC2050E90 FC2060E100 FC2070E120 FC2090E150 FC20100E170 FC2138G80 FC2150G90 FC2160G100 FC2170G120 FC2190G150 FC21100G170 FCL18100C160 FCL1938E80 FCL1950E90 FCL1960E100 FCL1970E120 FCL1990E150 FCL19100E160 FCL2138G80 FCL2150G90 FCL2160G100 FCL2170G120 FCL2190G150 FCL21100G160 FCRL1870C162 FCRL18100C185 FCRL1970E162 FCRL19100E185 FCHL1960E90 FCHL1970E120 FCHL19100E160 FCW1938
    1) PINION™ PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; 2) PINION™ PGA-PCL Knotless Suture - Absorbable Polyglycolic Acid - Poly (Glycolide-Co-Caprolactone) Knotless Suture
    Secret Line up (FCL18100C160 FCL19100E160 FCL1990E150 FCL2190G150 ); i-Thread (FCL18100C160 FCL19100E160 FCL1990E150 FCL2190G150)
    MINT Product Family (Including MINT, MINT Lift, and MINT-I Sutures), MINT Lift ML 1043, MINT Lift ML 1013, MINT Lift 1019, MINT Lift Mini 1014
    PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorable Surgical Suture
    PDO Max Suture with Dual Needle
    WEGO-PDO Barbed Suture
    MINT Product Family
    STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device
    DemeDIOX Barbed Absorbable Surgical Suture
    Viola
    PDS Barbed Suture, PDO MAXX Threads
    STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices, STRATAFIX Spiral PDS Plus Knotless Tissue Control Devices, STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Devices, STRATAFIX Spiral MONOCRYL Knotless Tissue Control Devices
    Miracu
    DemeTECH DemeDIOX absorbable surgical suture
    Omega VL
    RELI REDIDIOX Dyed, RELI REDIDIOX, RELI REDIDIOX Undyed
    Y.JACOBS YOUNG'S THREAD Synthetic Absorbable Surgical Fixation Suture,
    DW-1C
    Filbloc
    J+PRAS YOUNG'S Thread
    STRATAFIX Spiral PDS Plus Knotless Tissue Control Device
    STRATAFIX SYMMETRIC PDS PLUS KNOTLESS TISSUE CONTROL DEVICES
    TRANQUILL BARBED DEVICE
    QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN
    MINT
    ORTHOCORD
    QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN
    QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE (POLYDIXANONE)
    DIGITEX SUTURE DELIVERY SYSTEM, DIGITEXPOLYPROPYLENE SUTURE CARTRIDGE SIZE 0, WITH NEEDLE AND WITHOUT NEEDLE, DIGITEX
    QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE (POLYDIOXANONE)
    PDS(TM) BARBED SUTURES
    VITAL SUTURES, SUTUREX, CIRUGIA PERUANA
    PDM, VILET, VILET QUICK, MONO Q, PLAIN GUT:# 6 CHROMIC GUT
    DEMETECH POLYDIOXANONE SYNTHETIC MONOFILAMENT (PDO) ABSORBABLE SUTURE
    PD SYNTH, ABSORBABLE (POLY DIOXANONE) SUTURE
    WG-SURGICAL SUTURES WITH NEEDLE
    QUILL SELF-RETAINING SYSTEM (SRS) COMPRISED OF POLYDIOXANONE (PDO)
    DOUBLE ARMED MENISCAL NEEDLES WITH SIZE #2-0 ORTHOCORD, MENISCAL NEEDLE WITH WIRE EYELET & 3 FREE STRANDS OF SIZE #2-0
    QUILL SELF-RETAINING SYSTEM (SRS) COMPRISED OF PDO (POLYDIOXANONE
    QUILL SELF-RETAINING SYSTEM (SRS) SYNTHETIC ABSORBABLE SURGICAL SUTURE MATERIAL
    SHARPOINT PDO (POLYDIOXANONE) SUTURES
    PDS PLUS ANTIBACTERIAL SUTURE
    CONTOUR THREAD SYNTHETIC ABSORBABLE PDO BARBED SUTURE
    QUILL SYNTHETIC ABSORBABLE BARBED SUTURE
    UNICRYL M
    BLUE ORTHOCORD SUTURE
    QUILL SYNTHETIC ABSORBABLE BARBED 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