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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
OB
Reference & Predicate Devices
N/A
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.

§ 884.4340 Fetal vacuum extractor.

(a)
Identification. A fetal vacuum extractor is a device used to facilitate delivery. The device enables traction to be applied to the fetal head (in the birth canal) by means of a suction cup attached to the scalp and is powered by an external vacuum source. This generic type of device may include the cup, hosing, vacuum source, and vacuum control.(b)
Classification. Class II (performance standards).