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ECHO-3-22: Echotip Ultra and EUSN-1, EUSN-3: Echotip Ultrasound Needle

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K171596

by Wilson-Cook Medical, Inc.

Identifiers

510(k) Number
K171596 FDA 510(k)
FDA Product Code
FCG FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 876.1075 FDA 510(k)
Regulation Number
876.1075 FDA 510(k)
Advisory Committee
Gastroenterology, Urology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Echotip Ultrasound Needle is a biopsy needle designed for endoscopic ultrasound-guided procedures. It integrates ultrasound imaging with needle guidance to facilitate precise tissue sampling in abdominal and thoracic organs, including the pancreas, liver, and lymph nodes. The device combines real-time imaging with a fine needle aspiration or core biopsy capability, enabling clinicians to target lesions with enhanced accuracy during endoscopic ultrasound examinations.

This device is supplied as a single-use, sterile instrument for use in clinical settings such as gastroenterology and urology. It is classified as a Class II medical device under FDA regulations and has received FDA 510(k) clearance and MDD compliance. The Echotip Ultra and EUSN variants (EUSN-1, EUSN-3) are intended for use with endoscopic ultrasound systems, adhering to MRI safety standards for non-ferromagnetic materials. Proper storage and handling are required to maintain sterility and functionality.

Frequently asked questions

What specialties primarily use the Echotip Ultrasound Needle, and why is it designed for these fields?

The Echotip Ultrasound Needle is primarily used in gastroenterology and urology, as indicated by its advisory committee classification and medical specialty description. It is designed for these fields because it combines endoscopic ultrasound guidance with fine needle aspiration or core biopsy capabilities, enabling precise tissue sampling in abdominal and thoracic organs like the pancreas, liver, and lymph nodes—common targets in these specialties.

Is the Echotip Ultrasound Needle reusable, or is it intended for single-use only?

The device is explicitly labeled as a single-use, sterile instrument for clinical settings. This ensures patient safety and maintains sterility, as reuse could compromise integrity and introduce infection risks. Always follow manufacturer guidelines for proper disposal after one use.

What safety considerations should clinicians keep in mind when using the Echotip Ultrasound Needle, particularly regarding imaging equipment?

The Echotip Ultra and EUSN variants are designed to adhere to MRI safety standards for non-ferromagnetic materials, meaning they are compatible with endoscopic ultrasound systems that incorporate imaging technology. Clinicians should verify compatibility with their specific ultrasound equipment to avoid interference or safety hazards during procedures.

How should the Echotip Ultrasound Needle be stored to preserve its sterility and functionality?

Since it is a single-use, sterile device, storage instructions emphasize maintaining sterility until use. The packaging should remain intact and unopened until immediately before procedure. After opening, the needle must be used promptly, and any unused portions should be discarded per manufacturer guidelines to prevent contamination or degradation.

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
Wilson-Cook Medical, Inc.

Sources (2)

  • FDA 510(k) K171596 24 fields · synced Oct 6, 2026
  • EUDAMED 1 fields · synced May 18, 2026