ClearTip
ClearTip FNA and FNB Types are intended for ultrasonically guided fine needle aspiration of submucosal and extraluminal lesions of the gastrointestinal tract. The filing describes a…
ClearTip FNA and FNB Types are intended for ultrasonically guided fine needle aspiration of submucosal and extraluminal lesions of the gastrointestinal tract. The filing describes a manually operated endoscopic instrument for obtaining gastrointestinal tissue specimens.
The instrument includes a handle with an insertion part, syringe, stopcock, and connector. The needle advances to the target for aspiration; a stylet aids insertion and is removed for injection and aspiration. The filing says it passes through an endoscope working channel and is supplied sterile for single-patient use.
Listed Item
EBUS-TBNA 22G / Adaptor
Instrument and Procedure
The filing identifies the aspiration purpose, principal components, needle use, and handling conditions.
Who Else Makes It
Concentrated in Jiangsu (2), Zhejiang (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Micro-Tech (Nanjing) Co., Ltd. | Nan Jing | Jiangsu | Contract manufacturer | 49 |
| Promisemed Hangzhou Meditech Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 21 |
| Suzhou Leapmed Healthcare Corporation | Suzhou | Jiangsu | Contract manufacturer | 3 |
Record
| Listed by | Finemedix, South Korea |
|---|---|
| FDA product code | FCG |
| Device type | Biopsy Needle |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1075 |
| Establishment | Manufacturer |
| 510(k) | K250994 |
| Record published | 2026-03-24 |
| Record revised | 2019-07-12 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, serial number |
| Packaging | Box |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| FM-CTA002F | In distribution | |
| FM-CTA004NO | In distribution | |
| FM-CTB011 | In distribution | |
| FM-CTA004NP | In distribution | |
| FM-CTB013N | In distribution | |
| FM-CTB001 | In distribution | |
| FM-CTB011N | In distribution | |
| FM-CTB013 | In distribution | |
| FM-CTB012 | In distribution | |
| FM-CTA002 | In distribution | |
| FM-CTA011N | In distribution | |
| FM-CTA004C | In distribution | |
| FM-CTA013N | In distribution | |
| FM-CTA011 | In distribution | |
| FM-CTA004NCP | In distribution | |
| FM-CTA004NCO | In distribution | |
| FM-CTA001 | In distribution | |
| FM-CTA012 | In distribution | |
| FM-CTA012N | In distribution | |
| FM-CTA003 | In distribution | |
| FM-CTB003 | In distribution | |
| FM-CTA004 | In distribution | |
| FM-CTB012N | In distribution | |
| FM-CTB002 | In distribution | |
| FM-CTA013 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Biopsybell | Biopsybell SRL | 227 |
| Biopsybell SRL | Biopsybell SRL | 130 |
| Medline Industries, Inc. | Medline Industries, Inc. | 98 |
| Themy | M.D.L. S.R.L. | 61 |
| SemiCut | M.D.L. S.R.L. | 46 |
| Temno® | Merit Medical Systems, Inc. | 37 |
| Temno | Carefusion 2200, Inc. | 36 |
| CorVocet™ | Merit Medical Systems, Inc. | 34 |
| Truguide | Bard Peripheral Vascular, Inc. | 31 |
| Temno Evolution® | Merit Medical Systems, Inc. | 28 |
| Magnum | Bard Peripheral Vascular, Inc. | 22 |
| SemiCut Coax. | M.D.L. S.R.L. | 22 |
Showing 12 of 115. All products under Biopsy Needle
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K250994 | 2025-08-21 |
| K231267 | 2023-06-30 |
| K180363 | 2018-11-01 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.