EchoTip Ultra Ultrasound Needle
510(k) K083330
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK083330 | Date6 Feb 2009 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- FCG
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.1075
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The EchoTip Ultra Ultrasound Needle is a biopsy needle designed for endoscopic ultrasound (EUS) procedures. It is classified as a biopsy needle and is used to obtain tissue samples from targeted lesions within the gastrointestinal tract, including submucosal and extramural areas, as well as bile ducts, pancreatic ducts, and cystic structures. The device integrates ultrasound guidance to enhance precision during sampling.
This needle is supplied as a single-use, sterile disposable device and is intended for use within the accessory channel of an ultrasound endoscope. It is regulated under FDA 510K clearance (K083330) and falls under Class II medical devices (regulation number 876.1075). The device is available in various gauge sizes, as indicated by the associated FEI numbers, and is designed for use in gastroenterology and urology settings. Storage and handling follow standard sterile medical device protocols.
Other devices from Cook Endoscopy
Questions
AI-generated answers, 1 Oct 2026
What is the EchoTip Ultra Ultrasound Needle used for?
The EchoTip Ultra Ultrasound Needle is designed specifically for endoscopic ultrasound (EUS) procedures. It allows clinicians to obtain targeted tissue samples from difficult-to-reach areas such as submucosal lesions, extramural regions, bile ducts, pancreatic ducts, and cystic structures within the gastrointestinal tract. The integrated ultrasound guidance ensures precise needle placement, improving the accuracy of biopsies in gastroenterology and urology settings.
How is the EchoTip Ultra Ultrasound Needle supplied and what are its sterility and reuse specifications?
The EchoTip Ultra Ultrasound Needle is supplied as a single-use, sterile disposable device. This design ensures patient safety by eliminating the risk of cross-contamination between procedures. Due to its single-use nature, it is not intended for reuse, and each unit must be discarded after a single procedure to maintain sterility and regulatory compliance.
What gauge sizes are available for the EchoTip Ultra Ultrasound Needle?
The EchoTip Ultra Ultrasound Needle is available in multiple gauge sizes, each identified by a unique FEI number. These sizes are tailored to accommodate various clinical needs, including different tissue types and procedural requirements. The specific FEI numbers listed in the regulatory records represent the available models, ensuring compatibility with a range of endoscopic ultrasound applications.
How should the EchoTip Ultra Ultrasound Needle be stored?
The EchoTip Ultra Ultrasound Needle must be stored according to standard sterile medical device protocols. This includes maintaining the device in its original, sealed packaging until ready for use. Storage should be in a clean, dry environment, protected from physical damage, extreme temperatures, and direct sunlight. Adhering to these guidelines ensures the device remains sterile and functional for its intended single-use procedure.
Is the EchoTip Ultra Ultrasound Needle compatible with all ultrasound endoscopes?
The EchoTip Ultra Ultrasound Needle is designed for use within the accessory channel of an ultrasound endoscope, but compatibility depends on the specific dimensions and specifications of the endoscope being used. Clinicians should verify that the needle’s outer diameter and length align with their endoscope’s channel specifications to ensure safe and effective insertion. Always consult the manufacturer’s instructions for compatibility details.