EchoTip AcuCore Ultrasound Biopsy Needle (ECHO-BX-3-22)
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K230909 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 AcuCore Ultrasound Biopsy Needle (ECHO-BX-3-22) is a single-use endoscopic ultrasound (EUS) biopsy needle designed for obtaining tissue samples. It falls under the category of a biopsy needle, featuring a cobalt-chromium needle cannula with a Franseen tip for precise tissue acquisition during endoscopic procedures.
This device is supplied sterile and intended for single-use within the gastrointestinal tract, enabling physicians to sample submucosal and extramural lesions, lymph nodes, and intraperitoneal masses. It is compatible with ultrasound endoscopes and adheres to FDA 510(k) clearance standards, with a regulatory classification under 876.1075. The needle consists of a handle, sheath, and stylet, ensuring ease of use in clinical settings.
Frequently asked questions
What types of tissue samples can the EchoTip AcuCore Ultrasound Biopsy Needle obtain during endoscopic procedures?
The EchoTip AcuCore Ultrasound Biopsy Needle is designed for obtaining tissue samples from submucosal and extramural lesions, lymph nodes, and intraperitoneal masses within the gastrointestinal tract. Its Franseen tip and endoscopic ultrasound compatibility allow precise targeting of these areas during procedures.
Is the EchoTip AcuCore Ultrasound Biopsy Needle reusable or intended for single-use?
The device is explicitly intended for single-use only, as stated in its description. This ensures patient safety and sterility, as it is supplied sterile and not designed for repeated use.
How is the EchoTip AcuCore Ultrasound Biopsy Needle supplied, and what components does it include?
The needle is supplied sterile and includes a handle, sheath, and stylet, all of which are designed for ease of use during endoscopic ultrasound-guided biopsy procedures. The components work together to facilitate precise tissue acquisition.
What regulatory pathway was followed for the FDA clearance of this device, and which advisory committee was involved?
The EchoTip AcuCore Ultrasound Biopsy Needle received FDA 510(k) clearance under the traditional review pathway, classified under 876.1075. The Gastroenterology and Urology (GU) Advisory Committee was involved in the review process, reflecting its relevance to both specialties.
What materials is the needle cannula made of, and how does this affect its performance?
The needle cannula is constructed from cobalt-chromium, a durable alloy known for its strength and resistance to deformation. This material choice enhances precision and longevity during biopsy procedures, ensuring reliable performance for targeting hard-to-reach lesions.
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. Sources consulted: EchoTip® ClearCore™ EUS Biopsy Needle - Cook Medical, EchoTip® Ultra Endoscopic Ultrasound Needle - Cook Medical, EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22) (K230909 ..., K230909 - EchoTip AcuCore Ultrasound Biopsy Needl... | FDA 510(k)
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K230909 | Class II | Active |
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Manufacturer
- Manufacturer
- Cook Ireland, Ltd.
Sources (1)
- FDA 510(k) K230909 24 fields · synced Oct 6, 2026