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Cook Vacuum Pump

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K160753

by William A. Cook Australia Pty. Ltd.

Identifiers

510(k) Number
K160753 FDA 510(k)
FDA Product Code
MQG FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 884.6120 FDA 510(k)
Regulation Number
884.6120 FDA 510(k)
Advisory Committee
Obstetrics/Gynecology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Cook Vacuum Pump is a Class II medical device classified as an accessory for assisted reproduction procedures. It is designed to facilitate aspiration and evacuation during gynecological and obstetric interventions, ensuring precise control of vacuum pressure for clinical applications such as endometrial biopsy or uterine cavity assessment.

This device is supplied as a reusable medical instrument and is intended for use in clinical settings, including obstetrics and gynecology. It operates under sterile conditions when used in procedural environments and adheres to regulatory standards as outlined in the Medical Device Directive (MDD) and FDA 510(k) clearance (K160753). The pump is engineered for compatibility with associated gynecological tools and systems, with specifications governed by regulation number 884.6120.

Frequently asked questions

What clinical procedures is the Cook Vacuum Pump designed to assist with, and how does it provide control during these procedures?

The Cook Vacuum Pump is specifically designed as an accessory for assisted reproduction and gynecological/obstetric interventions. It facilitates aspiration and evacuation during procedures like endometrial biopsy or uterine cavity assessment by delivering precise vacuum pressure control. This ensures accurate and safe removal or sampling of tissue while maintaining clinical standards for these sensitive applications.

Is the Cook Vacuum Pump intended for single-use or reusable applications, and how does this impact its use in clinical settings?

The Cook Vacuum Pump is supplied as a reusable medical instrument, meaning it is engineered for repeated use in clinical settings like obstetrics and gynecology. Reusability requires adherence to strict cleaning, sterilization, and maintenance protocols to ensure patient safety and device integrity between procedures. Its design aligns with regulatory standards for reusable Class II devices in these specialties.

What regulatory pathways does the Cook Vacuum Pump follow, and how does this affect its availability or use in different markets?

The Cook Vacuum Pump has undergone FDA 510(k) clearance (K160753) and complies with the Medical Device Directive (MDD) in Europe, confirming its compliance with U.S. and EU regulatory standards. These pathways ensure the device meets safety, performance, and manufacturing requirements for use in obstetrics/gynecology procedures. Availability may vary by region based on local regulatory approvals, but these clearances validate its suitability for clinical use in markets where they apply.

How is the Cook Vacuum Pump intended to integrate with other gynecological tools, and what compatibility considerations should clinicians keep in mind?

The Cook Vacuum Pump is engineered for compatibility with associated gynecological tools and systems, ensuring seamless integration during procedures like endometrial biopsy or uterine cavity assessment. Clinicians should verify that connected accessories (e.g., catheters or cannulas) meet the pump’s vacuum specifications and regulatory standards. The device’s design adheres to regulation number 884.6120, which governs its performance and interoperability in assisted reproduction and gynecological contexts.

What storage or handling requirements should be followed for the Cook Vacuum Pump to maintain its performance and sterility between uses?

As a reusable device, the Cook Vacuum Pump must be stored in a clean, dry environment after each use to prevent contamination or damage. Before reuse, it undergoes sterilization processes (e.g., autoclaving or chemical sterilization) as per manufacturer guidelines to ensure sterility for subsequent procedures. Proper maintenance, including lubrication and inspection of seals, is critical to preserve its vacuum performance and longevity in clinical settings.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

United States Active

FDA_510K

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Manufacturer

Manufacturer
William A. Cook Australia Pty. Ltd.
FDA Applicant
William A. Cook Australia Pty. , Ltd.

Sources (2)

  • FDA 510(k) K160753 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced Jun 20, 2026