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

    SURGIDYNE VARIDYNE, MODEL 140-2I & MODEL 140-2ID

    K Number: K860030 · Decision Feb 12, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    98
    Registration Numbers
    98
    Same Product Code
    158
    Applicant Total
    6
    Review Days
    37

    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
    SURGIDYNE VARIDYNE, MODEL 140-2I & MODEL 140-2ID
    K Number
    K860030
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4780
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Surgidyne, Inc.
    Date Received
    January 6, 1986
    Decision Date
    February 12, 1986
    Product Code
    BTA
    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
    BTA Pump, Portable, Aspiration (Manual Or Powered)

    Similar 510(k) Clearances

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

    Momcozy Nasal Aspirator (BN007)

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

    Baby Nasal Aspirator (BN006, BN006-A, BN006-B, BN006-C, BN006-D, BN02; BN008, BN008-A, BN008-B, BN008-C, BN008-D, BC-021)

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

    Suction Pump (SU-90)

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

    Electric nasal aspirator (BC027, BC030, BC033, BC035, BC035B)

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

    Electric Nasal Aspirator (DT10 and DT50, DX80, DX85, DX86 and DX90)

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

    Electric nasal aspirator (BC026, BC025, BC023, BC028, BC029, BC036)

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

    Other Clearances by Surgidyne, Inc.

    K Number Device Name
    K892334 LEONARD TUBE
    K883582 VARIDYNE MODEL 250 SUCTION DRAINAGE SYSTEM
    K864822 VARIDYNE 550, MODELS 12E,12M,24E & 24M SUCTION SYS
    K852180 SURGIDYNES VARIDYNE 350-2I & 350-2C CORDLESS ELEC.
    K850634 SURGIDYNE SURGIFLO C.W.S. DRAIN PRODUCTS