Single Use Aspiration Needle NA-U401SX
The ViziShot 2 NA-U401SX is a single use aspiration needle for ultrasound guided sampling of submucosal and extramural lesions in the tracheobronchial tree and gastrointestinal tract. It is…
The ViziShot 2 NA-U401SX is a single use aspiration needle for ultrasound guided sampling of submucosal and extramural lesions in the tracheobronchial tree and gastrointestinal tract. It is used with compatible Olympus ultrasound endoscopes.
A handle slider advances the needle from its sheath into the target tissue. The insertion section contains the sheath, needle and stylet, while an aspiration port accepts a syringe to draw the sample. Needle dimples enhance ultrasound visibility.
Endoscope Connection
The handle attaches to the endoscope instrument channel through the MAJ-1414 adapter biopsy valve. An oval portion of the needle supports angulation. The product may be supplied with or without an associated VACLOK syringe and stopcock.
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) | K160098 |
| Record published | 2024-07-03 |
| Record revised | 2024-04-22 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 5 |
| Distribution end date | 2022-08-19 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| NA-U401SX-4021 | In distribution | |
| NA-U401SX-4021 | In distribution | |
| NA-U401SX-4022 | In distribution | |
| NA-U401SX-4022 | In distribution | |
| NA-U401SX-4022 | In distribution | |
| NA-U401SX-4022 | Withdrawn |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 |
Recalls Naming This Product
2 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Olympus Corporation of the Americas | 510(k) number | 2023-03-31 | Class III | Employee error | Product non-conformance pertaining to the angle of the needle does not meet manufacturing specifications and remained unbent, resulting to slight resistance experienced during needle advancement and retraction. | 2058 (Boxes; 5 per Box) |
| Olympus Corporation of the Americas | 510(k) number | 2023-03-31 | Class III | Employee error | Product non-conformance pertaining to the angle of the needle does not meet manufacturing specifications and remained unbent, resulting to slight resistance experienced during needle advancement and retraction. | 1297 (Boxes; 5 per Box) |
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.