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

    CIV-FLEX HOLSTER COVER, MODEL STERILE, LATEX-FREE

    K Number: K002546 · Decision Oct 31, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    207
    Registration Numbers
    207
    Same Product Code
    360
    Applicant Total
    29
    Review Days
    75

    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
    CIV-FLEX HOLSTER COVER, MODEL STERILE, LATEX-FREE
    K Number
    K002546
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1075
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    CIVCO Medical Instruments Co., Inc.
    Date Received
    August 17, 2000
    Decision Date
    October 31, 2000
    Product Code
    KNW
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KNW Instrument, Biopsy

    Similar 510(k) Clearances

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

    Promisemed VeriEcto Automatic Biopsy Needles

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Control Module; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Disposable Probe, 8 gauge; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Disposable Targeting Set, 8 gauge; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Foot Switch; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Reusable Tray; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Battery Char

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    ZeniCore™ Automatic Biopsy Instrument (863212100 / ZeniCore Automatic Biopsy Device 12ga x 10cm with Coaxial Introducer Kit); ZeniCore™ Automatic Biopsy Instrument (863212130 / ZeniCore Automatic Biopsy Device 12ga x 13cm with Coaxial Introducer Kit); ZeniCore™ Automatic Biopsy Instrument (863214100 / ZeniCore Automatic Biopsy Device 14ga x 10cm with Coaxial Introducer Kit); ZeniCore™ Automatic Biopsy Instrument (863214130 / ZeniCore Automatic Biopsy Device 14ga x 13cm with Coaxial

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    EnCor EnCompass™ Breast Biopsy and Tissue Removal System

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Resitu Slider 09 (RESL09)

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Forcyte Autograft Harvest Kit

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology
    View all

    Other Clearances by CIVCO Medical Instruments Co., Inc.

    K Number Device Name
    K231783 VitroPRO
    K222052 VitroPRO
    K211270 CIV-Clear cover
    K163313 ASTRA TEE Transesophageal Probe Reprocessor, ASTRA VR Endovaginal/Endorectal Probe Reprocessor
    K160806 Verza Guidance System
    K131161 EX3 STEPPER, CLASSIC STEPPER, MULTI-PURPOSE WORKSTATION STEPPER; MICRO-TOUCH, MICRO-TOUCH LP, MULIT-PURPOSE WORKSTATION,
    K131528 NON-PYROGENIC ULTRASOUND TRANSDUCER COVER
    K080072 MRI PATIENT POSITIONING DEVICES
    K013721 SYNTHETIC POLYSIOPRENE ULTRASOUND TRANSDUCER COVER
    K992152 GENERAL PURPOSE TRANSDUCER STANDOFF, BIOPSY TRANSDUCER STANDOFF, BI-PLANE ENDOCAVITY TRANSDUCER STANDOFF
    Search all 29 clearances from CIVCO Medical Instruments Co., Inc. →