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

    VANGUARD REPROCESSED ELECTRIC BIOPSY FORCEPS

    K Number: K011800 · Decision Sep 27, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    3
    Applicant Total
    33
    Review Days
    111

    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
    VANGUARD REPROCESSED ELECTRIC BIOPSY FORCEPS
    K Number
    K011800
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.4300
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Vanguard Medical Concepts, Inc.
    Date Received
    June 8, 2001
    Decision Date
    September 27, 2001
    Product Code
    NLU
    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
    NLU Forceps, Biopsy, Electric, Reprocessed

    Similar 510(k) Clearances

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

    REPROCESSED HOT BIOPSY FORCEPS

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

    REPROCESSED SINGLE USE DEVICES BIOPSY FORCEPS

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

    SISS REPROCESSED HOT BIOPSY FORCEPS, LAPAROSCOPIC, ENDOSCOPIC AND ELECTROSURGICAL SURGICAL INSTRUMENTS AND ACCESSORIES

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

    Other Clearances by Vanguard Medical Concepts, Inc.

    K Number Device Name
    K053051 VANGUARD REPROCESSED EXTERNAL FIXATION DEVICES
    K051616 VANGUARD REPROCESSED EXTERNAL FIXATION DEVICES
    K051180 VANGUARD REPROCESSED EXTERNAL FIXATION DEVICES
    K051043 VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS
    K050763 VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS
    K043198 VANGUARD REPROCESSED ARTHROSCOPIC WANDS
    K043253 VANGUARD REPROCESSED DILATING TIP AND BLUNT TROCARS
    K043594 VANGUARD REPROCESSED BLADED TROCAR, NON-BLADED TROCAR, TROCAR ACCESSORIES
    K043225 VANGUARD REPROCESSED ULTRASONIC SCALPEL
    K043315 VANGUARD REPROCESSED HAND-ACTIVATED ULTRASONIC SCALPEL
    Search all 33 clearances from Vanguard Medical Concepts, Inc. →