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510(k) Data Aggregation

    K Number
    K060413
    Device Name
    INTACT BREAST LESION EXCISION SYSTEM AND ADVANCE
    Manufacturer
    INTACT MEDICAL CORPORATION
    Date Cleared
    2006-04-27

    (70 days)

    Product Code
    KNW
    Regulation Number
    876.1075
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K003190,K021577,K020031,K042170,K050737,K052246,K003297
    Why did this record match?
    Device Name :

    INTACT BREAST LESION EXCISION SYSTEM AND ADVANCE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The intact™ BLES is indicated to provide tissue samples for diagnostic sampling of breast abnormalities.

    The intact™ BLES is intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality.

    The intact™ BLES is intended to provide breast tissue for histologic examination with partial removal of a palpable abnormality.

    The extent of a histologic abnormality cannot always be readily determined from palpation or imaged appearance. Therefore, the extent of removal of the palpable or imaged evidence of an abnormality does not predict the extent of removal of a histologic abnormality, e.g., malignancy. When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures.

    In instances when a patient presents with a palpable abnormality that has been classified as benign through clinical and/or radiological criteria (e.g., fibroadenoma, fibrocystic lesion), the intact™ BLES may also be used to partially remove such palpable lesions. Whenever breast tissue is removed, histologic evaluation of the tissue is the standard of care. When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures.

    Device Description

    Common or Usual Name: Electrosurgical Generator
    Trade or Proprietary Name: intact™ Breast Lesion Excision System (BLES)
    Classification Name: Electrosurgical Cutting & Coagulation Device & Accessories (21 C.F.R. § 878.4400) Biopsy Instrument (21 C.F.R. § 876.1075)

    AI/ML Overview

    This document does not contain information on acceptance criteria or a study proving the device meets acceptance criteria. The provided text is a 510(k) summary for the intact™ Breast Lesion Excision System (BLES), detailing its name, submitter, predicates, and intended use. It also includes an FDA letter confirming substantial equivalence. There is no performance study data or acceptance criteria outlined.

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