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

    VESSELOOPS

    K Number: K905240 · Decision Feb 6, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    231
    Registration Numbers
    231
    Same Product Code
    66
    Applicant Total
    7
    Review Days
    78

    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
    VESSELOOPS
    K Number
    K905240
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Sparta Surgical Corp.
    Date Received
    November 20, 1990
    Decision Date
    February 6, 1991
    Product Code
    KDC
    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
    KDC Instrument, Surgical, Disposable

    Similar 510(k) Clearances

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

    DISPOSABLE SURGICAL SCISSORS AND FORCEPS

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

    SURGIMED BREAST LOCALIZATION NEEDLE WIRE SET

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

    THERMUFF BAG

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

    MANUAL SURGICAL INSTRUMENTS

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

    DISPOSABLE CAUTERY ABRASIVE PAD

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

    INSTRUMENT ORGANIZER

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

    Other Clearances by Sparta Surgical Corp.

    K Number Device Name
    K965187 SPECTRUM II, SPECTRUM PLUS, AND SPECTRUM MAX-SD
    K945313 SPARTA HYDROGEL WOUND DRESSING
    K922729 SPARTA WET DRESSING, SODIUM CHLORIDE
    K905384 DAVID SIMMONDS ANESTHESIA EXTENSION TUBES
    K896085 SURGI-BRUSH
    K896084 MICROSPEARS