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

    FLO-STAT FLUID MONITORING SYSTEM

    K Number: K954775 · Decision May 10, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    153
    Registration Numbers
    153
    Same Product Code
    337
    Applicant Total
    8
    Review Days
    206

    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
    FLO-STAT FLUID MONITORING SYSTEM
    K Number
    K954775
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.1720
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Gynecare Innovation Center
    Date Received
    October 17, 1995
    Decision Date
    May 10, 1996
    Product Code
    HET
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HET Laparoscope, Gynecologic (And Accessories)

    Similar 510(k) Clearances

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

    SIRIUS Endoscope System (PR-SI-1230)

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    i-Cut

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    SIRIUS Endoscope System

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Video Endoscopy System, 3D Video Endoscopy System

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    SurroundScope System

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology
    View all

    Other Clearances by Gynecare Innovation Center

    K Number Device Name
    K980393 SOPRANO CRYO-THERAPY SYSTEM
    K971305 FEMRX FOCUSED MONOPOLAR (FMP) OPERA STAR SYSTEM
    K964441 FEMRX FOCUSED MONOPOLAR (FAP) OPERASTAR SYSTEM [OUTPATIENT ENDOSCOPIC RESECTION AND ABLATION (OPERA)] [SPECIALIZED TISSU
    K964892 FEMRX TURP SR SYSTEM (TS27XX-YY/TS24XX-YY)
    K963872 FEMRX MORCELLATOR SYSTEM
    K962506 [SPECIALIZED TISSUE ASPIRATING RESECTOSCOPE (STAR)]
    K954648 FEMRX OPERASTAR SYSTEM