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

    AMS FASCIAL-ANCHORING SYSTEM

    K Number: K010277 · Decision Mar 26, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    0
    Applicant Total
    72
    Review Days
    55

    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
    AMS FASCIAL-ANCHORING SYSTEM
    K Number
    K010277
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4300
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    American Medical Systems, Inc.
    Date Received
    January 30, 2001
    Decision Date
    March 26, 2001
    Product Code
    NEH
    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
    NEH Anchor, Fascial

    Other Clearances by American Medical Systems, Inc.

    K Number Device Name
    K132655 RETROARC RETROPUBIC SLING SYSTEM
    K112842 AMS ELEVATE PC
    K100807 MINIARC PRECISE SINGLE-INCISION SLING SYSTEM MODEL: 720181, 720191
    K092735 GREENLIGHT XPS LASER SYSTEM
    K090934 PFR SLING SYSTEM, PART OF THE AMS PELVIC FLOOR REPAIR SYSTEM
    K090663 AMS SPECTRA CONCEALABLE PENILE PROSTHESIS
    K090713 ELEVATE PROLAPSE REPAIR SYSTEM WITH PC COATED INTEPRO LITE- APICAL AND POSTERIOR PROLAPSE REPAIR SYSTEM, ANTERIOR AND AP
    K082677 AMS ELEVATE ANTERIOR & APICAL PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE
    K082730 AMS ELEVATE APICAL AND POSTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE, AMS ELEVATE APICAL AND POSTERIOR PROLAPSE
    K082006 AMS SPECTRA CONCEALABLE PENILE PROSTHESIS
    Search all 72 clearances from American Medical Systems, Inc. →