Single Use Aspiration Needle NA-U201H
The Olympus NA-U201H is a single-use aspiration needle used with an Olympus ultrasound endoscope to sample lesions in or around the gastrointestinal tract. Ultrasound guidance helps…
The Olympus NA-U201H is a single-use aspiration needle used with an Olympus ultrasound endoscope to sample lesions in or around the gastrointestinal tract. Ultrasound guidance helps position the needle for fine needle aspiration of submucosal or extramural targets.
The device has a handle, needle and sheath, with needle sizes from 19 to 25 gauge. A supplied VACLOK syringe and stopcock connect to the aspiration port on the handle to apply suction.
Supply and Targets
The needle and syringe are individually packaged sterile and bundled in one carton. Indicated targets include pancreatic, mediastinal and perirectal masses and lymph nodes accessible through the specified ultrasound-guided gastrointestinal procedure.
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 | Olympus Medical Systems Corp., Japan |
|---|---|
| FDA product code | FCG |
| Device type | Biopsy Needle |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1075 |
| Establishment | Specification developer, Manufacturer, Exporter |
| 510(k) | K181994 |
| Record published | 2018-11-06 |
| Record revised | 2024-04-22 (version 6) |
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 |
| Packaging | Pack of 5 |
| Distribution end date | 2022-02-21 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| NA-U201H-8025 | In distribution | |
| NA-U201H-8022 | In distribution | |
| NA-U201H-8019 | In distribution | |
| NA-U201H-8022 | Withdrawn | |
| NA-U201H-8025 | Withdrawn | |
| NA-U201H-8019 | Withdrawn |
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 |
| ClearTip | Finemedix | 25 |
| Magnum | Bard Peripheral Vascular, Inc. | 22 |
Showing 12 of 115. All products under Biopsy Needle
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K252646 | 2025-10-24 |
| K180668 | 2018-11-15 |
| K181994 | 2018-10-31 |
| K180449 | 2018-06-08 |
| K160098 | 2016-03-22 |
| K151738 | 2015-11-20 |
| K050503 | 2005-05-12 |
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.