BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    CONTOUR THREAD SYNTHETIC ABSORBABLE PDO BARBED SUTURE

    K Number: K053380 · Decision Jan 18, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    84
    Registration Numbers
    84
    Same Product Code
    63
    Applicant Total
    22
    Review Days
    44

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    CONTOUR THREAD SYNTHETIC ABSORBABLE PDO BARBED SUTURE
    K Number
    K053380
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4840
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Surgical Specialties Corp
    Date Received
    December 5, 2005
    Decision Date
    January 18, 2006
    Product Code
    NEW
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    NEW Suture, Surgical, Absorbable, Polydioxanone

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (NEW), ordered by most recent decision date.

    Barbed PDO Suture

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Devices

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    PDS™ Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Miracu™ Polydioxanone (PDO) Suture and Needle (MONO)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    V-soft Line™ Barbed Surgical Suture (Various)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    PINION™ PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; PINION™ PGA-PCL Knotless Suture - Absorbable Poly (Glycolide-Co-Caprolactone) Knotless Suture

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery
    View all

    Other Clearances by Surgical Specialties Corp

    K Number Device Name
    K141625 POLYSYN SURGICAL SUTURE
    K141558 QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE
    K140227 MONODERM SURGICAL SUTURE
    K080985 QUILL SELF-RETAINING SYSTEM (SRS) COMPRISED OF POLYDIOXANONE (PDO)
    K080680 QUILL SELF-RETAINING SYSTEM (SRS) COMPRISED OF PDO (POLYDIOXANONE
    K071989 QUILL SELF-RETAINING SYSTEM (SRS) SYNTHETIC ABSORBABLE SURGICAL SUTURE MATERIAL
    K072028 QUILL SELF-RETAINING SYSTEM (SRS) COMPRISED OF MONODERM
    K063680 SHARPOINT PDO (POLYDIOXANONE) SUTURES
    K052962 OPTIMIZED BARB DESIGN
    K052437 MODIFIED MONODERM MONOFILAMENT, SYNTHETIC, ABSORBABLE SUTURE
    Search all 22 clearances from Surgical Specialties Corp →