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510(k) Data Aggregation

    K Number
    K013460
    Device Name
    SWIFT LOW PROFILE CUP (PRO CUP)
    Manufacturer
    SWIFT DELIVERY PRODUCTS
    Date Cleared
    2002-01-17

    (91 days)

    Product Code
    HDB
    Regulation Number
    884.4340
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    SWIFT LOW PROFILE CUP (PRO CUP)

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

    INDICATIONS FOR USE:

      1. Non-reassuring fetal status.
    • Failure of the fetus to deliver spontaneously following an appropriately 2. managed second stage.
    • Maternal need to avoid voluntary expulsive effort. 3.
      1. Inadequate maternal expulsive effort.
    • Selective shortening of the second stage when the fetal head is at the outlet 5. as defined by ACOG technical bulletin # 196 Aug. 1994.
    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) premarket notification letter from the FDA regarding the Swift Low Profile Cup (Pro Cup) fetal vacuum extractor. It does not contain any information about acceptance criteria, device performance, or details of a study.

    Therefore, I cannot provide the requested information in the table or answer the subsequent questions based on the provided text. The letter only states that the device is substantially equivalent to legally marketed predicate devices.

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