Areus(TM) Adapt Endoscopic Ultrasound Aspiration Needle(FNA)
Maximum insertion portion diameter:2.5mm,Needle:19G,Maximum needle length:80mm,Needle structure: Butted needle, Working channel: Greater than or equal to 2.8mm,Working Length:1197~1237mm,…
Maximum insertion portion diameter:2.5mm,Needle:19G,Maximum needle length:80mm,Needle structure: Butted needle, Working channel: Greater than or equal to 2.8mm,Working Length:1197~1237mm, FNA needle
Who Else Makes It
Registered in Jiangsu.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Micro-Tech (Nanjing) Co., Ltd. | Nan Jing | Jiangsu | Contract manufacturer | 49 |
Record
| Listed by | Micro-Tech (Nanjing) Co., Ltd., China |
|---|---|
| FDA product code | ODG |
| Device type | Endoscopic Ultrasound System, Gastroenterology-Urology |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| Establishment | Contract manufacturer, Contract steriliser, Manufacturer |
| 510(k) | K212852 |
| Record published | 2023-06-28 |
| Record revised | 2025-12-08 (version 4) |
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, manufacturing date |
| Packaging | Box, case of 5, transport case of 2, transport box of 2 |
| Sizes | Needle gauge 19 to 22 G |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| EUS-19-0-F | Needle Gauge 19 G | In distribution |
| EUS-19-0-FS1 | Needle Gauge 19 G | In distribution |
| EUS-22-0-F | Needle Gauge 22 G | In distribution |
| EUS-19-0-FS2 | Needle Gauge 19 G | In distribution |
| EUS-22-0-FS2 | Needle Gauge 22 G | In distribution |
| EUS-22-0-FS1 | Needle Gauge 22 G | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Pentax | Hoya Corporation | 22 |
| Areus(TM) Endoscopic Ultrasound Aspiration Needle (FNA) | Micro-Tech (Nanjing) Co., Ltd. | 12 |
| Pentax Medical | Hoya Corporation | 6 |
| Water-resistant Cap | Olympus Medical Systems Corp. | 6 |
| Expect | Boston Scientific Corporation | 4 |
| Ultrasonic Probe | Olympus Medical Systems Corp. | 4 |
| BALLOON3 | Olympus Medical Systems Corp. | 3 |
| Acquire | Boston Scientific Corporation | 3 |
| Evis-EUS Image Cable | Olympus Medical Systems Corp. | 3 |
| Expect Slimline SL | Boston Scientific Corporation | 3 |
| Evis Exera II Ultrasound Gastrovideoscope | Olympus Medical Systems Corp. | 2 |
| Keyboard | Olympus Medical Systems Corp. | 2 |
Showing 12 of 52. All products under Endoscopic Ultrasound System, Gastroenterology-Urology
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K212852 | 2021-12-06 |
| K172309 | 2017-09-29 |
Recalls
2 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2018-03-12 | Class II | Device Design | The combination of the firmness of the mass, the potential endoscope and elevator position combined with the force required to penetrate the mass may contribute to the breakage of the needle in the human body, which could cause injury. | 40 total | 2018-08-30 |
| 2018-03-12 | Class II | Device Design | The combination of the firmness of the mass, the potential endoscope and elevator position combined with the force required to penetrate the mass may contribute to the breakage of the needle in the human body, which could cause injury. | 40 total | 2018-08-30 |
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.