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

    PERSONALLY(TM), MODEL 241 SIZES 0-12,LEFT & RIGHT

    K Number: K864786 · Decision Jan 8, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    16
    Applicant Total
    54
    Review Days
    31

    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
    PERSONALLY(TM), MODEL 241 SIZES 0-12,LEFT & RIGHT
    K Number
    K864786
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.3800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Coloplast Corp.
    Date Received
    December 8, 1986
    Decision Date
    January 8, 1987
    Product Code
    GBI
    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
    GBI Material, External Aesthetic Restoration, Used With Adhesive

    Similar 510(k) Clearances

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

    FACTOR II PROSTHETIC SILICONE ELASTOMER

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

    AHH NATURAL BREAST FORM

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

    S.T.A.C.E.M. EXTERNAL BREAST PROSTHESIS MAMMARY

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

    AMOENA BREAST FORMS

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

    AMOENA BREAST FORMS

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

    PROSTHESIS OR SURGICAL PADS

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

    Other Clearances by Coloplast Corp.

    K Number Device Name
    K252140 Heylo™ System
    K251116 Luja Coudé
    K250270 Luja Set
    K242049 SureCath Set
    K241210 Luja Coude
    K242173 Retrace Ureteral Access Sheath (ASXL10, ASXL12, ACXL10, ACXL12, AXXL10, AXXL12, ALXL10, ALXL12)
    K242473 Altis Single Incision Sling System (519650); Aris Transobturator Sling System (519551); Supris Retropubic Sling System (519562)
    K233411 Folysil Silicone Catheter
    K231953 Biatain Fiber Ag (33570 - 5 cm x 5 cm / 2 in x 2 in); Biatain Fiber Ag (33572 - 10 cm x 12 cm / 4 in x 5 in); Biatain Fiber Ag (33574 - 15 cm x 15 cm / 6 in x 6 in); Biatain Fiber Ag (33576 - 2.5 cm x 46 cm / 1 in x 18 in); Biatain Fiber Ag (33578 - 20 cm x 30 cm / 8 in x 12 in)
    K233101 Luja Coude (20108 Male CH18 - large packaging)
    Search all 54 clearances from Coloplast Corp. →