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

    Golnit Nylon Monofilament Suture

    K Number: K212888 · Decision Mar 31, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    114
    Registration Numbers
    114
    Same Product Code
    56
    Applicant Total
    2
    Review Days
    202

    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
    Golnit Nylon Monofilament Suture
    K Number
    K212888
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    878.5020
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Antarma, LLC Dba Golnit Sutures
    Date Received
    September 10, 2021
    Decision Date
    March 31, 2022
    Product Code
    GAR
    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
    GAR Suture, Nonabsorbable, Synthetic, Polyamide

    Similar 510(k) Clearances

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

    Tissue Approximation System

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

    Tissue Approximation System (TAS)

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

    Non Absorbable Surgical Nylon Suture

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

    Crownjun Nylon Suture

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

    REXLON, REXSIL

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

    Aesculap Dafilon Nonabsorbable Polyamide Surgical Suture

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

    Other Clearances by Antarma, LLC Dba Golnit Sutures

    K Number Device Name
    K192088 GOLNIT Non-aborbable PTFE Surgical Suture