BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    BREAST STABILIZER

    K Number: K925874 · Decision Mar 16, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    840
    Registration Numbers
    840
    Same Product Code
    43
    Applicant Total
    7
    Review Days
    117

    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
    BREAST STABILIZER
    K Number
    K925874
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Bip USA, Inc.
    Date Received
    November 19, 1992
    Decision Date
    March 16, 1993
    Product Code
    MDM
    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
    MDM Instrument, Manual, Surgical, General Use

    Similar 510(k) Clearances

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

    FRONTLINE MEDICAL SAFETYNET GUIDEWIRE INTRODUCER

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    FUTUMEDS NO PATIENT CONTACT SAFETY LANCET WITH PALS SYSTEM

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    EUTROCHAR

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    ANDREWS INTRODUCER, MODEL ASI01

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    MICROVASIVE PULMONARY GUIDEWIRE

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    LIGHT SABER INTRODUCER NEEDLE

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery
    View all

    Other Clearances by Bip USA, Inc.

    K Number Device Name
    K024089 VACUFLASH BIOPSY SYSTEM
    K934371 BIP MULTI MODIFICATION
    K934370 BIP BIOPSY NEEDLE MODIFICATION
    K935457 LOCALIZATION WIRE OR MARKER - SURGICAL
    K925870 SPACER
    K925875 HORIZONTAL NEEDLE GUIDE ATTACHMENT