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

    Aesculap Slim Clip Applier

    K Number: K211572 · Decision Dec 13, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    13
    Applicant Total
    207
    Review Days
    206

    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
    Aesculap Slim Clip Applier
    K Number
    K211572
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4175
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Aesculap, Inc.
    Date Received
    May 21, 2021
    Decision Date
    December 13, 2021
    Product Code
    HCI
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HCI Applier, Aneurysm Clip

    Similar 510(k) Clearances

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

    Sugita AVM Microclip Applier

    FDA 510(k)
    FDA Class 2 ·Neurology

    Aesculap Slim Clip Applier

    FDA 510(k)
    FDA Class 2 ·Neurology

    Aesculap Slim Clip Applier Forceps

    FDA 510(k)
    FDA Class 2 ·Neurology

    MEDICON YASARGIL CLIP APPLYING FORCEPS

    FDA 510(k)
    FDA Class 2 ·Neurology

    SPETZLER ROUND HANDLE APPLIERS, MODELS C-3753, C-3753T, C-3754, C-3754T

    FDA 510(k)
    FDA Class 2 ·Neurology

    AESCULAP AXIAL CLIP APPLIER

    FDA 510(k)
    FDA Class 2 ·Neurology
    View all

    Other Clearances by Aesculap, Inc.

    K Number Device Name
    K242762 Aesculap Aicon® Series Container System
    K242003 XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter Set
    K223596 SQ.line KERRISON
    K214041 Aesculap AICON Container
    K203739 ELAN 4 Electro Motor System
    K202391 DIR 800
    K203461 Aesculap Caiman 12 Seal and Cut Technology System
    K202938 Aesculap Caiman 5 Seal and Cut Technology System
    K202124 Aesculap PAS-Port Proximal Anastomosis System
    K200950 Ventricular Catheter
    Search all 207 clearances from Aesculap, Inc. →