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

    AEON™ Endoscopic Powered Stapler

    K Number: K251482 · Decision Jul 11, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    76
    Registration Numbers
    76
    Same Product Code
    41
    Applicant Total
    9
    Review Days
    58

    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
    AEON™ Endoscopic Powered Stapler
    K Number
    K251482
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4740
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Lexington Medical, Inc.
    Date Received
    May 14, 2025
    Decision Date
    July 11, 2025
    Product Code
    GAG
    Advisory Committee
    General Hospital
    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
    GAG Stapler, Surgical

    Similar 510(k) Clearances

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

    da Vinci SP SureForm 45 Staplers and Reloads (SP1098)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Signia™ Circular Adapter (Standard Length) (SIGCIRSTND); Signia™ Circular Adapter XL Length (SIGCIRXL)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ECHELON 3000 45mm Compact Stapler (ECH45C); Echelon 3000 45mm Standard Stapler (ECH45S); Echelon 3000 45mm Long Stapler (ECH45L); Echelon 3000 60mm Compact Stapler (ECH60C); Echelon 3000 60mm Standard Stapler (ECH60S); Echelon 3000 60mm Long Stapler (ECH60L)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    AEON Endoscopic Powered Stapler (Short/AEPH060); AEON Endoscopic Powered Stapler (Medium/AEPH160); AEON Endoscopic Powered Stapler (Long/AEPH260)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    GIA™ Stapler with Tri-Staple™ Technology

    FDA 510(k)
    FDA Class 2 ·General Hospital

    EEA™Circular Stapler with Tri-Staple™ Technology and OrVil™ Transoral Circular Stapler Anvil

    FDA 510(k)
    FDA Class 2 ·General Hospital
    View all

    Other Clearances by Lexington Medical, Inc.

    K Number Device Name
    K234039 AEON Endoscopic Powered Stapler (Short/AEPH060); AEON Endoscopic Powered Stapler (Medium/AEPH160); AEON Endoscopic Powered Stapler (Long/AEPH260)
    K222210 AEON Endoscopic Stapler
    K201882 AEON Endoscopic Stapler
    K192235 AEON Laparoscopic Instruments
    K182380 AEON Endoscopic Stapler
    K180114 AEON Retrieval Bag
    K173443 AEON Endoscopic Stapler
    K171589 AEON Endoscopic Stapler