BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    Promisemed VeriEcto Automatic Biopsy Needles

    K Number: K261196 · Decision May 12, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    207
    Registration Numbers
    207
    Same Product Code
    360
    Applicant Total
    35
    Review Days
    29

    Basic Information

    Device Name
    Promisemed VeriEcto Automatic Biopsy Needles
    K Number
    K261196
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    876.1075
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Promisemed Hangzhou Meditech Co., Ltd.
    Date Received
    April 13, 2026
    Decision Date
    May 12, 2026
    Product Code
    KNW
    Advisory Committee
    Gastroenterology, Urology
    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
    KNW Instrument, Biopsy

    Similar 510(k) Clearances

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

    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

    Disposable Biopsy Needle

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

    Other Clearances by Promisemed Hangzhou Meditech Co., Ltd.

    K Number Device Name
    K261045 Verifine Safety Lancets
    K254273 Verisafe Safety Sterile Needles (SSN)
    K250192 Verisafe Safety Retractable Insulin Syringes
    K250961 Blood collection tube holders
    K251138 Promisemed Safety Huber Needles
    K243332 Promisemed Safety Huber Needles
    K243806 Safety Winged Blood Collection Sets
    K240675 Endoscopic Injection Needles
    K242632 Verifine® Pen Needles
    K234124 Single Use Hemoclips
    Search all 35 clearances from Promisemed Hangzhou Meditech Co., Ltd. →