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510(k) Data Aggregation

    K Number
    K961683
    Device Name
    JJ SKINNER CAREKITS MINOR SURGICAL PROCEDURE TRAY
    Manufacturer
    J.J. SKINNER, INC.
    Date Cleared
    1996-05-10

    (9 days)

    Product Code
    LRO,79L
    Regulation Number
    878.4370
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K903545
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The JJ Skinner CareKits™ Minor Surgical Procedure Tray/Kit is intended to be used by Healthcare professionals for minor surgical procedures. Minor surgical procedures are those generally performed on an outpatient basis, under topical anesthetics. These may include dermological excisions or circumcisions.

    Device Description

    The devices are an assembly of medical products within Tyvek®/polyethylene breather pouch. The medical products include medical devices, and drugs that are 510(k) approved devices, grandfathered, or exempt. The primary purpose of the assembly is for the convenience of the Medical practitioner. The kit is sterile, single use and disposable. The kits are custom made for the customer, who specifies the name of the kit (i.e.) as well as the contents. Attachment 5 includes a list of the medical components that may be requrested by the customer.

    AI/ML Overview

    This document is a 510(k) summary for a medical device called "JJ Skinner CareKits™ Minor Surgical Procedure Tray/Kit". It explicitly states "No clinical evaluations were completed." This means there is no study described within this document that proves the device meets specific acceptance criteria based on performance.

    Therefore, I cannot provide the requested information.

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