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510(k) Data Aggregation

    K Number
    K963765
    Device Name
    STRYKER STRYKEFLOW ELECTROCAUTERY PROBES
    Manufacturer
    Stryker Endoscopy
    Date Cleared
    1997-01-31

    (134 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K934094,K954726
    Why did this record match?
    Reference Devices :

    K934094, K954726

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

    Not Found

    Device Description

    The Stryker StrykeFlow Electrocautery Probe is an electrosurgical device which enables the user to have the functions of electrocautery cutting and coagulation along with suction and irrigation in the same tool when used in combination with the Stryker Strykeflow Suction / Irrigator (K934094 and K954726). The Electrocautery Probe includes a variety of tip configurations for those laparoscopic surgical procedures where the delivery of electrosurgical current, irrigation, and suction via a single probe is desirable. The tips are packaged non-sterile for reusable purposes, and validated to packaging standard ASTM 4169.

    AI/ML Overview

    This document is a 510(k) summary for a medical device submitted to the FDA in 1997. It describes the device, its intended use, and its equivalence to predicate devices. However, the document does not contain any information about acceptance criteria or a study proving that the device meets those criteria.

    Therefore, I cannot provide the requested table or additional details. The information necessary to answer your questions is not present in the provided text.

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