Single Use Aspiration Needle NA-U200H
The Olympus NA-U200H is a single-use needle for ultrasound-guided fine needle aspiration and biopsy of lesions in or around the gastrointestinal tract. It is used with an Olympus ultrasound…
The Olympus NA-U200H is a single-use needle for ultrasound-guided fine needle aspiration and biopsy of lesions in or around the gastrointestinal tract. It is used with an Olympus ultrasound endoscope to sample submucosal and extramural targets.
A handle controls the needle and sheath assembly. Available sizes range from 19 to 25 gauge, and a bundled VACLOK syringe with stopcock attaches to the handle’s aspiration port to provide suction.
Sampling and Supply
Indicated targets include pancreatic, mediastinal and perirectal masses and lymph nodes. The needle and syringe are supplied in separate sterile packages within one carton. This version supports both fine needle aspiration and fine needle biopsy.
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) | K180449 |
| Record published | 2018-07-02 |
| Record revised | 2024-04-22 (version 5) |
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-U200H-8019S | In distribution | |
| NA-U200H-8019 | In distribution | |
| NA-U200H-8025 | In distribution | |
| NA-U200H-8022 | In distribution | |
| NA-U200H-8022S | In distribution | |
| NA-U200H-8025 | Withdrawn |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.