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

    OMED SILICONE INSTRUMENT COVERS

    K Number: K810883 · Decision Apr 23, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    231
    Registration Numbers
    231
    Same Product Code
    66
    Applicant Total
    9
    Review Days
    22

    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
    OMED SILICONE INSTRUMENT COVERS
    K Number
    K810883
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Omega-Med Intl., Inc.
    Date Received
    April 1, 1981
    Decision Date
    April 23, 1981
    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 Omega-Med Intl., Inc.

    K Number Device Name
    K842603 OMED DISPOS. INSTRUMENT GUARDS
    K832441 SUTURE-AID BOOTIES
    K830484 OMED IDENT-I-BAND
    K822284 COMPLY NEUROMUSCULAR STIMULATOR
    K821334 OMED FABRIC INSTRUMENT COVERS-RADIOPAQ
    K813499 OMED DISPOSABLE BULLDOG
    K810269 OMED FABRIC INSTRUMENT COVERS
    K810260 OMED SILICONE LOOPS