ClearTip TBNA Type
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- ClearTip EUDAMED
- Device Name
- Endoscopic Ultrasound-Guided Tissue Acquisition Needle EUDAMED
- Model / Reference
- FM-CTA015NCO EUDAMEDFM-CTA015NCPX EUDAMEDFM-CTA011N EUDAMEDFM-CTA014NO EUDAMEDFM-CTB013N EUDAMEDFM-CTA014NCO EUDAMEDFM-CTB011N EUDAMEDFM-CTA015NCP EUDAMEDFM-CTA014NCP EUDAMEDFM-CTA015NPX EUDAMEDFM-CTA012 EUDAMEDFM-CTA014NP EUDAMEDFM-CTA015NO EUDAMEDFM-CTA014NCPX EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809327356317 EUDAMED08809327356300 EUDAMED08809327356003 EUDAMED08809327355877 EUDAMED08809327356041 EUDAMED08809327355884 EUDAMED08809327356034 EUDAMED08809327357796 EUDAMED08809327355938 EUDAMED08809327357567 EUDAMED08809327355990 EUDAMED08809327355945 EUDAMED08809327357550 EUDAMED08809327355914 EUDAMED
- Basic UDI-DI
- 0880932735CTGT EUDAMED
- 510(k) Number
- K251478 FDA 510(k)
- FDA Product Code
- KTI FDA 510(k)
- EMDN Code
- A01020102 ASPIRATION FINE NEEDLES AND KITS EUDAMED
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 874.4680 FDA 510(k)
- Regulation Number
- 874.4680 FDA 510(k)
- Market of Registration
- Italy EUDAMED
- Advisory Committee
- Ear, Nose, Throat FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
The ClearTip Transbronchial Needle Aspiration (TBNA) is a bronchoscope accessory designed for transbronchial needle aspiration procedures. It facilitates the collection of tissue samples from mediastinal and hilar lymph nodes, aiding in the diagnosis of conditions such as lymphoma, infections, or malignancies within the thoracic cavity.
This device is supplied as a single-use, sterile accessory compatible with flexible bronchoscopes. It is intended for use in clinical settings such as operating rooms or bronchoscopy suites, adhering to standard aseptic techniques. The device is classified under FDA regulation 874.4680 as a Class II medical device, with FDA 510(k) clearance and MDR authorization. Multiple registration numbers and FEI numbers are associated with its regulatory submissions.
Frequently asked questions
What clinical procedures is the ClearTip TBNA Type specifically designed to assist with, and why is this important for my practice?
The ClearTip TBNA Type is designed to facilitate transbronchial needle aspiration (TBNA) procedures, which involve collecting tissue samples from mediastinal and hilar lymph nodes. This is particularly important for diagnosing conditions such as lymphoma, infections, or malignancies within the thoracic cavity. Since these conditions often require precise tissue sampling for accurate diagnosis, this device helps clinicians obtain samples efficiently during bronchoscopy, reducing the need for more invasive procedures.
Is the ClearTip TBNA Type reusable or single-use, and what does this mean for my workflow and infection control?
The ClearTip TBNA Type is supplied as a single-use device, meaning each unit is intended for one procedure only. This design aligns with standard aseptic techniques in clinical settings like operating rooms or bronchoscopy suites, minimizing infection risks and ensuring patient safety. Single-use also simplifies workflow by eliminating the need for cleaning, sterilization, or reprocessing between patients.
How should I store the ClearTip TBNA Type to maintain its sterility and functionality before use?
Since the device is sterile upon packaging, it should be stored in its original, unopened packaging to preserve sterility. The packaging should be kept in a clean, dry environment away from direct sunlight, extreme temperatures, or moisture. Always check the expiration date on the packaging before use to ensure the device remains effective and safe for clinical procedures.
What types of bronchoscopes is the ClearTip TBNA Type compatible with, and are there any specific considerations for compatibility?
The ClearTip TBNA Type is designed as an accessory for flexible bronchoscopes, meaning it is intended to be used alongside compatible bronchoscopes during TBNA procedures. While the exact compatibility details (e.g., connector sizes or shaft diameters) are not specified in the data, it is critical to verify compatibility with your specific bronchoscope model before use. Always consult the manufacturer’s instructions or your device representative to ensure proper fit and functionality.
What regulatory pathways has the ClearTip TBNA Type undergone, and how does this affect its availability in different markets?
The ClearTip TBNA Type has received FDA 510(k) clearance and MDR (Medical Device Regulation) authorization, indicating it meets regulatory standards in the U.S. and European Economic Area (or markets adhering to MDR). These clearances confirm the device’s safety and effectiveness for its intended use. While the data does not specify availability in other regions, the regulatory status suggests it is commercially distributed in markets where these pathways apply. Always verify local regulatory approvals or consult the manufacturer for market-specific availability.
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
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K251478 | Class II | Active |
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Manufacturer
- Manufacturer
- Finemedix Co., Ltd.
Sources (15)
- FDA 510(k) K251478 24 fields · synced Sep 18, 2026
- EUDAMED ef619eff-70b4-4ead-b258-3e961d33dc57 61 fields · synced Jun 20, 2026
- EUDAMED 6b252993-74f5-4b79-aead-fcd7e2ed91eb 61 fields · synced Jun 20, 2026
- EUDAMED cda44704-f56d-4a37-aa19-6b744ed1fc3e 61 fields · synced Jul 9, 2026
- EUDAMED f9953a3f-4d06-4c17-bb2e-786c59b441e6 61 fields · synced Jul 9, 2026
- EUDAMED 319370cc-273e-4834-b0da-86b54dd58495 61 fields · synced Jul 12, 2026
- EUDAMED 15b66a23-fd9c-4807-bcfa-b6df067f13d7 61 fields · synced Jul 12, 2026
- EUDAMED 4193299e-d81e-40c8-adb5-36115fc85ecd 61 fields · synced Jul 13, 2026
- EUDAMED e54f1c9f-34a2-4ca2-914e-81982c2506c4 61 fields · synced Jul 15, 2026
- EUDAMED 88a0521b-fb8a-455a-bd3b-7a69fa9a07de 61 fields · synced Jul 15, 2026
- EUDAMED 1b90ced9-8997-47e9-a313-f4ba536fe3b0 61 fields · synced Jul 15, 2026
- EUDAMED dbf673de-aa6d-4138-a525-54d2521bb702 61 fields · synced Jul 16, 2026
- EUDAMED 43bd2c80-d770-4b4f-8a7d-b6ac73f9dc5e 61 fields · synced Jul 21, 2026
- EUDAMED e730a9fa-1a86-4404-aec8-210dfc089250 61 fields · synced Jul 24, 2026
- EUDAMED 5bcb9d00-db43-49cc-94e7-449a9b6c5ca6 61 fields · synced Jul 30, 2026