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510(k) Data Aggregation

    K Number
    K970712
    Device Name
    LAPARO-TENSER
    Manufacturer
    L & T S.N.C. DI E. LUCINI & C.
    Date Cleared
    1998-07-21

    (510 days)

    Product Code
    HET
    Regulation Number
    884.1720
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Laparo-Tenser is intended for use as a laparoscopic retractor in gasless laparoscopic procedures. the Laparo-Tenser creates a gasless cavity to permit direct viewing of the organs within the peritoneal cavity for the purpose of performing diagnostic and surgical procedures.

    Device Description

    Laparo-Tenser Laparoscopic Abdominal Retractor

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a medical device called the "Laparo-Tenser Laparoscopic Abdominal Retractor." It is a regulatory approval document, not a study report or clinical trial summary.

    Therefore, the input document does not contain the information requested regarding acceptance criteria and a study proving a device meets those criteria. The document only confirms that the device is substantially equivalent to a predicate device already on the market, allowing it to be marketed.

    Specifically, it lacks:

    • A table of acceptance criteria and reported device performance.
    • Details about a study, sample sizes, data provenance, expert qualifications, or adjudication methods.
    • Information on MRMC comparative effectiveness studies or standalone algorithm performance.
    • Details about ground truth establishment or training set sample sizes.
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