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

    SPONGE, RICHARDS WOUND DRAINAGE SYSTEM

    K Number: K760257 · Decision Aug 9, 1976
    View on FDA
    Classifications
    1
    FEI Numbers
    213
    Registration Numbers
    213
    Same Product Code
    95
    Applicant Total
    48
    Review Days
    21

    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
    SPONGE, RICHARDS WOUND DRAINAGE SYSTEM
    K Number
    K760257
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4680
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Richard'S Medical Equip., Inc.
    Date Received
    July 19, 1976
    Decision Date
    August 9, 1976
    Product Code
    GCY
    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
    GCY Apparatus, Suction, Single Patient Use, Portable, Nonpowered

    Similar 510(k) Clearances

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

    REDYROB-CLOSED WOUND DRAINAGE SYSTEM

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

    ODONTIT AUTOGENOUS BONE COLLECTION DEVICE

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

    CORDIS SUCTION RESERVOIR - MODEL NUMBER: 910-500

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

    PENROSE DRAIN MODELS 6001 - 6007

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

    MACRO SUCTION TUBE MODEL NO 10061

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

    PRESSURE IRRIGATING SYSTEM

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

    Other Clearances by Richard'S Medical Equip., Inc.

    K Number Device Name
    K830793 PATIENT GUIDED ELBOW & SHOULDER EXERC
    K823837 RMC TOTAL KNEE SYSTEM
    K823726 SPECTRON CONVERSION ENDOPROSTHESIS CUP
    K823724 SPECTRON NECK REPLACEMENT PROSTHESIS
    K823723 SPECTRON PROXIMAL FEMORAL PROSTHESIS
    K823722 SPECTRON LONG, STRAIGHT FEMORAL PROSTHES
    K823727 SPECTRON PRIMARY STEM FEMORAL PROSTHES
    K830153 RICHARDS INTRA-ARTICULAR SHAVER BLADES
    K830154 COLLES FRACTURE FRAME
    K823725 SPECTRON PROTRUSIO CUP
    Search all 48 clearances from Richard'S Medical Equip., Inc. →