Morrison Steerable Needle
FDA 510(k)Class II (US FDA 510(k))
by Apriomed AB
Identifiers
- 510(k) Number
- K150625 FDA 510(k)
- FDA Product Code
- KNW 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 Morrison Steerable Needle is a fine-needle aspiration (FNA) biopsy needle designed for precise, steerable access to deep-seated targets within the body. Its flexible, steerable design enables real-time navigation under imaging guidance, allowing clinicians to navigate around anatomical obstacles or sensitive structures during procedures.
This device is supplied as a single-use, sterile needle in a 21-gauge configuration, intended for use in interventional radiology, gastroenterology, and urology settings. It is approved for aspiration, injection, and biopsy applications, with FDA 510(k) clearance (K150625) under the Gastroenterology and Urology advisory committees. Compatibility with imaging modalities ensures accurate placement during live feedback-guided procedures.
Frequently asked questions
What types of medical specialties can use the Morrison Steerable Needle, and why is its design particularly useful in those fields?
The Morrison Steerable Needle is designed for use in interventional radiology, gastroenterology, and urology. Its flexible, steerable design is particularly useful in these fields because it allows clinicians to navigate around anatomical obstacles or sensitive structures during procedures like fine-needle aspiration (FNA) biopsies, aspiration, or injections. This precision is critical in deep-seated targets where traditional rigid needles may struggle to reach or avoid harming surrounding tissues.
Is the Morrison Steerable Needle intended for single-use only, and if so, why does this matter for clinical workflows?
Yes, the Morrison Steerable Needle is supplied as a single-use, sterile device. This matters for clinical workflows because single-use needles reduce the risk of cross-contamination between patients, minimize the need for reprocessing, and ensure consistent performance since reuse could compromise sterility or structural integrity. It also aligns with infection control best practices in sterile procedures.
What gauge is the Morrison Steerable Needle, and how does this affect its clinical applications?
The Morrison Steerable Needle is supplied in a 21-gauge configuration. A 21-gauge needle offers a balance between tissue penetration and sample retrieval or injection volume, making it suitable for fine-needle aspiration (FNA) biopsies, core sampling, or fluid aspiration in interventional procedures. The gauge size is ideal for accessing deep-seated lesions while minimizing trauma to surrounding tissues.
How does the steerable feature of this needle improve accuracy during procedures compared to traditional needles?
The steerable design of the Morrison Needle enables real-time navigation under imaging guidance (e.g., ultrasound or fluoroscopy), allowing clinicians to adjust the needle’s path dynamically. This is especially valuable when navigating complex anatomical areas, avoiding blood vessels or organs, or accessing targets that are obscured by obstacles. Traditional rigid needles lack this flexibility, which can limit precision and increase procedural risks.
What imaging modalities is the Morrison Steerable Needle compatible with, and why is this important for clinicians?
The Morrison Steerable Needle is designed to be compatible with standard imaging modalities used for guidance, such as ultrasound and fluoroscopy. This compatibility is important because it allows clinicians to visualize the needle’s position in real time, ensuring accurate placement of the needle tip at the target site. Live feedback from imaging reduces the risk of misplacement, off-target sampling, or complications during procedures.
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: Morrison Steerable Needle® - Home, Products - Home, AprioMed | Morrison Steerable Needle
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K150625 | Class II | Active |
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Manufacturer
- Manufacturer
- Apriomed AB
Sources (1)
- FDA 510(k) K150625 24 fields · synced Sep 19, 2026