BEUDAMED
    Product Code: NEW FDA class 2 21 CFR 878.4840

    Suture, Surgical, Absorbable, Polydioxanone

    General, Plastic Surgery

    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.

    View on FDA
    510(k)s
    58
    FEI Numbers
    86
    Registration Numbers
    86
    Unique Applicants
    40
    Years Active
    23

    Basic Information

    Product Code
    NEW
    Device Class
    FDA class 2
    Regulation Number
    878.4840
    Medical Specialty
    General, Plastic Surgery
    Review Panel
    SU
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✓
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    510(k) Clearance History

    Loading...

    Related 510(k) Clearances

    This FDA classification is associated with 58 510(k) clearances via K numbers.

    K Number Device Name
    K250977 Suture-TOOL System
    K242835 Suture-TOOL System
    K242571 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
    K232246 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
    K240389 Secret Line up (FCL18100C160 FCL19100E160 FCL1990E150 FCL2190G150 ); i-Thread (FCL18100C160 FCL19100E160 FCL1990E150 FCL2190G150)
    K220549 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
    K212380 PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorable Surgical Suture
    K210871 PDO Max Suture with Dual Needle
    K201139 WEGO-PDO Barbed Suture
    K192423 MINT Product Family
    K192144 STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device
    K191361 DemeDIOX Barbed Absorbable Surgical Suture
    K190264 Viola
    K190245 PDS Barbed Suture, PDO MAXX Threads
    K182873 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
    K172602 Miracu
    K181582 DemeTECH DemeDIOX absorbable surgical suture
    K162366 Omega VL
    K161737 RELI REDIDIOX Dyed, RELI REDIDIOX, RELI REDIDIOX Undyed
    K160705 Y.JACOBS YOUNG'S THREAD Synthetic Absorbable Surgical Fixation Suture,
    K160761 DW-1C
    K150553 Filbloc
    K143413 J+PRAS YOUNG'S Thread
    K150670 STRATAFIX Spiral PDS Plus Knotless Tissue Control Device
    K141776 STRATAFIX SYMMETRIC PDS PLUS KNOTLESS TISSUE CONTROL DEVICES
    K133420 TRANQUILL BARBED DEVICE
    K132268 QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN
    K130191 MINT
    K123668 ORTHOCORD
    K123877 QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN
    K120827 QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE (POLYDIXANONE)
    K120284 DIGITEX SUTURE DELIVERY SYSTEM, DIGITEXPOLYPROPYLENE SUTURE CARTRIDGE SIZE 0, WITH NEEDLE AND WITHOUT NEEDLE, DIGITEX
    K113744 QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE (POLYDIOXANONE)
    K113004 PDS(TM) BARBED SUTURES
    K100780 VITAL SUTURES, SUTUREX, CIRUGIA PERUANA
    K100461 PDM, VILET, VILET QUICK, MONO Q, PLAIN GUT:# 6 CHROMIC GUT
    K082097 DEMETECH POLYDIOXANONE SYNTHETIC MONOFILAMENT (PDO) ABSORBABLE SUTURE
    K081001 PD SYNTH, ABSORBABLE (POLY DIOXANONE) SUTURE
    K073614 WG-SURGICAL SUTURES WITH NEEDLE
    K080985 QUILL SELF-RETAINING SYSTEM (SRS) COMPRISED OF POLYDIOXANONE (PDO)
    K080918 DOUBLE ARMED MENISCAL NEEDLES WITH SIZE #2-0 ORTHOCORD, MENISCAL NEEDLE WITH WIRE EYELET & 3 FREE STRANDS OF SIZE #2-0
    K080680 QUILL SELF-RETAINING SYSTEM (SRS) COMPRISED OF PDO (POLYDIOXANONE
    K071989 QUILL SELF-RETAINING SYSTEM (SRS) SYNTHETIC ABSORBABLE SURGICAL SUTURE MATERIAL
    K063680 SHARPOINT PDO (POLYDIOXANONE) SUTURES
    K061037 PDS PLUS ANTIBACTERIAL SUTURE
    K053380 CONTOUR THREAD SYNTHETIC ABSORBABLE PDO BARBED SUTURE
    K051609 QUILL SYNTHETIC ABSORBABLE BARBED SUTURE
    K043298 BLUE ORTHOCORD SUTURE
    K042285 UNICRYL M
    K042075 QUILL SYNTHETIC ABSORBABLE BARBED SUTURE
    K041048 POLYDIOXANONE SYNTHETIC ABSORBABLE SURGICAL SUTURE
    K040004 ORTHOCORD SUTURE
    K031216 MONOPLUS POLY-P-DIOXANONE MONOFILAMENT ABSORBABLE SURGICAL SUTURE
    K031443 LSI SOLUTIONS SUTURE QUICK LOAD PRODUCTS
    K030786 MONO-SWIFT
    K030212 MONODEK SYNTHETIC ABSORBABLE SURGICAL SUTURE
    K022666 PDO (POLYDIOXANONE) MONOFILAMENT SYNTHETIC ABSORBABLE SUTURE U.S.P.
    K013274 MONO-DOX, SYNTHETIC ABSORBABLE POLYDIOXANONE SURGICAL SUTURE,STERILE

    FEI Numbers

    This FDA classification entry is associated with 86 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 86 registration numbers. Click on an entry to view related FDA registrations.