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

    Cypris eXact Suturing System

    K Number: K233355 · Decision Jan 12, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    108
    Registration Numbers
    108
    Same Product Code
    84
    Applicant Total
    2
    Review Days
    105

    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
    Cypris eXact Suturing System
    K Number
    K233355
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.5010
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cypris Medical
    Date Received
    September 29, 2023
    Decision Date
    January 12, 2024
    Product Code
    GAW
    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
    GAW Suture, Nonabsorbable, Synthetic, Polypropylene

    Similar 510(k) Clearances

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

    STRATAFIX™ Spiral PRONOVA™ Unidirectional Knotless Tissue Control Device STRATAFIX™ Spiral PRONOVA™ Bidirectional Knotless Tissue Control Device

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

    Non absorbable Surgical Polypropylene Suture

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

    Vesseal

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

    DURAMESH Mesh Suture

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

    APTOS Threads – Polypropylene Surgical Sutures

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

    Deklene MAXX

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

    Other Clearances by Cypris Medical

    K Number Device Name
    K240185 Cypris eXact Suture Placement Device