Identifiers
- 510(k) Number
- K180363 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 Clear-Tip EUS-FNA is a biopsy needle used with an ultrasound endoscope for fine needle biopsy of submucosal lesions, mediastinal masses, lymph nodes, and intraperitoneal masses within or adjacent to the gastrointestinal tract. It is classified as a Class II device under regulation number 876.1075 and product code FCG.
The device received FDA 510(k) clearance (K180363) on November 1, 2018, and is substantially equivalent to a predicate device. It is supplied by Finemedix Co., Ltd. and is intended for use in gastroenterology and urology procedures.
Frequently asked questions
What is the Clear-Tip EUS-FNA used for?
The Clear-Tip EUS-FNA is a biopsy needle designed for fine needle aspiration of submucosal lesions, mediastinal masses, lymph nodes, and intraperitoneal masses located within or adjacent to the gastrointestinal tract when used with an ultrasound endoscope.
How is the Clear-Tip EUS-FNA supplied and is it reusable?
The Clear-Tip EUS-FNA is supplied by Finemedix Co., Ltd. as a single-use device; it is not intended for reuse, and reprocessing could compromise sterility and functionality.
What regulatory pathway was used for the Clear-Tip EUS-FNA?
The Clear-Tip EUS-FNA received FDA 510(k) clearance (K180363) on November 1, 2018, as a substantially equivalent Class II device under regulation 876.1075 and product code FCG.
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: Clear-Tip EUS-FNA (K180363) — FDA 510 (k) | Innolitics, PDF November 1, 2018 FINEMEDIX CO., LTD. Consultant Withus Group, Inc., PDF FINEMEDIX Co., Ltd. ℅ Priscilla Chu - accessdata.fda.gov
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K180363 | Class II | Active |
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Manufacturer
- Manufacturer
- Finemedix Co., Ltd.
Sources (1)
- FDA 510(k) K180363 24 fields · synced Sep 27, 2026