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

    HESSBURG-BFRRON TREPHINE

    K Number: K801585 · Decision Oct 3, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    222
    Registration Numbers
    222
    Same Product Code
    20
    Applicant Total
    4
    Review Days
    84

    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
    HESSBURG-BFRRON TREPHINE
    K Number
    K801585
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Precision Instruments, Inc.
    Date Received
    July 11, 1980
    Decision Date
    October 3, 1980
    Product Code
    EMF
    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
    EMF Knife, Surgical

    Similar 510(k) Clearances

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

    MOUNTABLE ENDOSCOPIC BLADE

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

    MOUNTABLE ENDOSCOPIC KNIFE

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

    MICROSURGICAL KNIVES

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

    MICROSURGERY RAZOR BLADE HOLDER

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

    MICROSURGICAL SCARIFIER

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

    VAN-TEC ENDOPYELOTOMY KNIFE

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

    Other Clearances by Precision Instruments, Inc.

    K Number Device Name
    K864520 BARRON ROTARY BLADE TREPHINE USING HESSBURG-BARRON
    K860648 BARRON TWIN BLADE TREPHINE FOR EPPIKARATOPHAKIA
    K843048 RING SUPPORTED TREPHINE FOR CORNEA TRANS