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

    HUMMER TRAK SYSTEM

    K Number: K990038 · Decision Feb 19, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    131
    Registration Numbers
    131
    Same Product Code
    90
    Applicant Total
    101
    Review Days
    44

    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
    HUMMER TRAK SYSTEM
    K Number
    K990038
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.4250
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Stryker Endoscopy
    Date Received
    January 6, 1999
    Decision Date
    February 19, 1999
    Product Code
    ERL
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece

    Similar 510(k) Clearances

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

    Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350, Piezomed Pro instruments (various tips) and accessories)

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    hekaDrill

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    ORiGO System

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    AMADEO, M-UK1015 (incl. attachments and accessories)

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    Celeris, Disposable Sinus Debrider

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    Pi Drive 2 Motor / Model Number 5407-150-000, Pi Drive 2 Plus Motor / Model Number 5407-350-000

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat
    View all

    Other Clearances by Stryker Endoscopy

    K Number Device Name
    K253602 Precision S 4K Sinuscope
    K261037 780 nm SPY Portable Handheld Imaging (SPY-PHI) System
    K260185 1688 4K Camera System with Advanced Imaging Modality; 1788 4K Camera System with Advanced Imaging Modality
    K260108 L12 LED Light Source with AIM
    K254014 Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice Control
    K253888 MOLLI 2 System
    K252010 SPY Laparoscope
    K252012 SPY Cystoscope/Hysteroscope
    K250544 Knotilus+ Biocomposite Knotless Anchor
    K250528 Stryker AlphaVent™ Knotless SP Biocomposite Anchor
    Search all 101 clearances from Stryker Endoscopy →