BEUDAMED
    FDA 510(k) FDA class 2 Unknown 🇺🇸 United States

    THOROCENTESIS KIT

    K Number: K910963 · Decision Jun 20, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    331
    Registration Numbers
    331
    Same Product Code
    83
    Applicant Total
    50
    Review Days
    106

    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
    THOROCENTESIS KIT
    K Number
    K910963
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6740
    Medical Specialty
    General Hospital
    Decision
    Unknown
    Applicant
    Megadyne Medical Products, Inc.
    Date Received
    March 6, 1991
    Decision Date
    June 20, 1991
    Product Code
    JOL
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    JOL Catheter And Tip, Suction

    Similar 510(k) Clearances

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

    STERILE SALINE FOR DEVICE CARE, STERILE WATER FOR DEVICE CARE, MODELS 2F7121, 2F8014

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PRIMARY CARE SOLUTIONS STERILE WATER DEVICE IRRIGATION

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PRIMARY CARE SOLUTIONS STERILE SALINE-0.9% SODIUM CHLORIDE FOR DEVICE IRRIGATION

    FDA 510(k)
    FDA Class 2 ·General Hospital

    WELCON STERILE WATER FOR DEVICE IRRIGATION; WELCON STERILE 0.9% NORMAL SALINE FOR DEVICE IRRIGATION

    FDA 510(k)
    FDA Class 2 ·General Hospital

    STERILE WATER AND 0.9% SODIUM CHLORIDE FOR IRRIGATION, USP

    FDA 510(k)
    FDA Class 2 ·General Hospital

    HYDROX SALINE SOLUTION 0.9% SODIUM CHLORIDE 4 OZ. CUP 120 ML 100 ML BOTTLE

    FDA 510(k)
    FDA Class 2 ·General Hospital
    View all

    Other Clearances by Megadyne Medical Products, Inc.

    K Number Device Name
    K233644 Megadyne Patient Return Electrode Pad - Universal Dual (model 0846), Megadyne Patient Return Electrode Pad - Universal Plus (model 0847), Megadyne Patient Return Electrode Pad - Universal Dual Plus (model 0848)
    K213696 ETHICON Megadyne Electrosurgical Generator
    K200250 Megadyne Smoke Evacuator, Megadyne Filter, Megadyne Fluid Trap, Megadyne Connect Cable, 1 m and 2.1 m, Megadyne RF Sensor
    K193145 Ethicon Megadyne Electrosurgical Generator, Bipolar Footswitch
    K191328 Megadyne Foot Switch
    K141587 E-Z CLEAR SMOKE EVACUATION ELECTROSURGICAL PENCIL;CLEAR NOZZLE EXTENTION, ULPA FILTER, CHARCOAL FILTER, ADAPTER
    K133726 MEGA SOFT UNIVERSAL PATIENT RETURN ELECTRODE
    K080741 MEGA SOFT REUSABLE PATIENT RETURN ELECTRODE
    K081791 E-Z CLEAN ELECTROSURGICAL ELECTRODE
    K072559 SUCTION COAGULATOR
    Search all 50 clearances from Megadyne Medical Products, Inc. →