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

    A & EM MEDICAL ELECTROSURGICAL PENCIL/ACCESSORIES

    K Number: K915300 · Decision Feb 18, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    823
    Registration Numbers
    823
    Same Product Code
    2306
    Applicant Total
    10
    Review Days
    89

    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
    A & EM MEDICAL ELECTROSURGICAL PENCIL/ACCESSORIES
    K Number
    K915300
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4400
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Alto Development Corp.
    Date Received
    November 21, 1991
    Decision Date
    February 18, 1992
    Product Code
    GEI
    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
    GEI Electrosurgical, Cutting & Coagulation & Accessories

    Similar 510(k) Clearances

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

    Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coating

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    CoolSeal Generator® (CSL-200-90)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    NEUROMARK System (NMK00301)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    LAP-iX2N

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    OsteoCool™ RF Ablation System; OsteoCool™ 2.0 RF Ablation System

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    MILAN System

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery
    View all

    Other Clearances by Alto Development Corp.

    K Number Device Name
    K964621 A & E MEDICAL ELECTROCAUTERY SUCTION TUBE WITH FINGER TIP ACTIVATOR BUTTON
    K932513 LABELING FOR MYO/WIRE II STERNOTOMY SUTURES
    K931537 A&E MEDICAL ELECTROSURG ELECTRO W/NON-STICK COAT
    K930528 A&E MEDICAL ELECTROSURGICAL CONNECTING CORDS
    K914193 A&E MEDICAL CORP DISPOS SUCT COAG W/NON STICK COAT
    K884783 RANEY CLIP
    K881413 ELECTRO-CAUTERY SUCTION TUBE
    K831867 PRESSURE MONITORING IV BOTTLE CAP
    K821518 MYO/CLIP