Areus Adapt Endoscopic Ultrasound Aspiration Needle, Tridemt Endoscopic Ultrasound Aspiration Needle
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K212852 FDA 510(k)
- FDA Product Code
- ODG FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.1500 FDA 510(k)
- Regulation Number
- 876.1500 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Areus Adapt Endoscopic Ultrasound Aspiration Needle and Tridemt Endoscopic Ultrasound Aspiration Needle are aspiration needles designed for endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA). These devices facilitate the sampling of targeted submucosal and extraluminal gastrointestinal lesions via the accessory channel of a compatible ultrasound videoendoscope, enabling diagnostic tissue acquisition in adult patients.
These single-use devices are intended for use in endoscopic ultrasound procedures within the gastroenterology and urology specialties. They are classified as Class II medical devices under regulation 876.1500 and have received FDA 510(k) clearance (K212852) and MDD authorization. The needles are supplied sterile and must be used within their specified expiration date. Compatibility with specific ultrasound videoendoscopes is required for proper functionality.
Frequently asked questions
What specialties are these aspiration needles primarily used in, and how does that relate to their design?
The Areus Adapt and Tridemt Endoscopic Ultrasound Aspiration Needles are designed for use in gastroenterology and urology specialties. Their purpose is to facilitate endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA), allowing clinicians to sample targeted lesions in the gastrointestinal tract or nearby structures (e.g., lymph nodes, pancreatic masses) via an ultrasound videoendoscope’s accessory channel. The needles are optimized for precision in these areas, where submucosal or extraluminal lesions require accurate, guided biopsy techniques.
Are these needles reusable, and if not, what does the single-use designation mean for clinical workflows?
Yes, these needles are single-use only. The designation means each needle is sterile upon packaging and must be discarded after a single procedure to maintain sterility and patient safety. Clinicians should check the expiration date on the packaging and avoid reuse, as reprocessing is not intended or validated by the manufacturer.
How do I ensure compatibility with my ultrasound videoendoscope, and what should I verify before use?
Compatibility is critical—these needles are designed to fit within the accessory channel of specific ultrasound videoendoscopes. While the manufacturer lists multiple compatible models (via registration numbers like `3003782610` or `3043585886`), you should verify your exact endoscope model against the provided list or consult your supplier. Ensure the needle’s outer diameter and length align with your endoscope’s specifications to avoid procedural complications.
What storage conditions are required to preserve sterility and functionality before use?
The needles are supplied sterile, but they must be stored in their original, unopened packaging to maintain sterility. Keep them in a clean, dry environment away from direct sunlight or extreme temperatures. Avoid exposure to moisture or contaminants, and use them before the expiration date printed on the packaging. Once opened, the needle should be used immediately.
What regulatory pathways have these devices undergone, and how does that affect their use in clinical practice?
The Areus Adapt and Tridemt needles have received FDA 510(k) clearance (K212852) under the Traditional pathway and MDD authorization in Europe. This means they’ve been evaluated for safety and effectiveness by regulatory bodies and are classified as Class II devices under regulation 876.1500. Clinicians can rely on these approvals to confirm the devices meet established standards for endoscopic ultrasound-guided aspiration, though local regulations may still apply.
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: PDF Areus TM Adapt Endoscopic Ultrasound Aspiration Needle (FNA) Trident TM ..., Areus(TM) Adapt Endoscopic Ultrasound Aspiration… - FDA.report, Areus(TM) Adapt Endoscopic Ultrasound Aspiration… - FDA.report
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K212852 | Class II | Active |
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Manufacturer
- Manufacturer
- Micro-Tech (Nanjing) Co., Ltd.
Sources (2)
- FDA 510(k) K212852 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 18, 2026