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

    SDC SILICONE SUMP DRAIN

    K Number: K843617 · Decision Oct 24, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    243
    Registration Numbers
    243
    Same Product Code
    76
    Applicant Total
    9
    Review Days
    40

    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
    SDC SILICONE SUMP DRAIN
    K Number
    K843617
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4200
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Science Development Corp.
    Date Received
    September 14, 1984
    Decision Date
    October 24, 1984
    Product Code
    GBX
    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
    GBX Catheter, Irrigation

    Similar 510(k) Clearances

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

    MOERAE VEIN PREPARATION KIT

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

    GRAFTGUARD PRESSURE CONTROLLING SYRINGE

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

    DEUTSCH ANTI-BLOCKAGE WOUND DRAIN

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

    GRAFTSAVER

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

    MISONIX IRRIGATION SYSTEM MOEDL BC20P

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

    DMC SAPHENOUS VEIN DISTENTION SYSTEM (SVDS)

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

    Other Clearances by Science Development Corp.

    K Number Device Name
    K842491 SDC SILICONE FORCEP SHODS PRODUCT
    K833355 SDC VASCULAR TIES
    K832090 SCD SKIN TEMP. SENSORS #3400 ETC
    K832391 QT-100 ELECTRONIC TEMP. MONITOR
    K832392 SDC ORAL-RECTAL TEMP. PROBE
    K830353 ESOPHAGEAL PROBE W/TEMP. INDICATOR
    K830329 ESOPHAGEAL STETHOSCOPE
    K830039 SDC RECTAL TEMP. PROBE PRODUCT #1020