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

    ULTRACELL SUCTION SPONGE

    K Number: K972635 · Decision Oct 1, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    243
    Registration Numbers
    243
    Same Product Code
    76
    Applicant Total
    24
    Review Days
    79

    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
    ULTRACELL SUCTION SPONGE
    K Number
    K972635
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4200
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Ultracell Medical Technologies, Inc.
    Date Received
    July 14, 1997
    Decision Date
    October 1, 1997
    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 Ultracell Medical Technologies, Inc.

    K Number Device Name
    K012196 ULTRACELL ABSORBENT STICK
    K972633 ULTRACELL SUCTION SPONGE
    K972634 ULTRACELL SUCTION SPONGE
    K973083 ULTRACELL NEURO SPONGES
    K973558 VISUAL ENDOSCOPIC NON-ALCOHOL ULTRACELL SPONGE (VENUS)
    K973085 ULTRACELL PACKING WITH SLEEVE
    K970328 ULTRACELL NEURO SPONGES
    K950647 ULTRACELL NEURO SPONGES
    K950370 ULTRACELL ORTHOPEDIC SPONGES
    K950373 ULTRACELL ORTHOPEDIC SPONGES
    Search all 24 clearances from Ultracell Medical Technologies, Inc. →