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

    MONOTEX

    K Number: K140415 · Decision Mar 26, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33
    Same Product Code
    16
    Applicant Total
    27
    Review Days
    36

    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
    MONOTEX
    K Number
    K140415
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    878.5035
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Riverpoint Medical
    Date Received
    February 18, 2014
    Decision Date
    March 26, 2014
    Product Code
    NBY
    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
    NBY Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene

    Similar 510(k) Clearances

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

    TissueStat

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

    GOLNIT Non-aborbable PTFE Surgical Suture

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

    Biotex

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

    StitchKit

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

    DemeTECH PTFE Nonabsorbable Surgical Suture

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

    PTFE SURGICAL SUTURE

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

    Other Clearances by Riverpoint Medical

    K Number Device Name
    K253024 ProZip Knotless Implant
    K252201 HS Fiber
    K252144 Iconix Speed Anchor; Iconix Speed HA+ Anchor
    K243323 Iconix Knotless Anchor
    K243203 OC JuggerKnotless Soft Anchor; OC JuggerLoop Soft Anchor
    K241282 RibFix Titan™ Fixation System
    K241577 Iconix® Anchor
    K240719 OC JuggerKnot Soft Anchor
    K240213 Iconix Knotless Anchor
    K240194 ProCinch, QuadCinch
    Search all 27 clearances from Riverpoint Medical →