Areus(TM) Endoscopic Ultrasound Aspiration Needle (FNA)
Sheath: 1.8mm, Needle: 0.5mm, Needle Length out of sheath: 80mm, Material: Co-Cr Alloy, Working channel is more than or equal to 2.8mm, Working Length: 1375~1415mm, EUS FNA needle
1manufacturer
12catalogue numbers in this listing
2510(k) clearances naming this product code
2recalls on this code
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) | K172309 |
| Record published | 2023-04-03 |
| Record revised | 2025-12-04 (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 20 |
| Sizes | Needle gauge 19 to 25 G |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| EUS-25-0-N | Needle Gauge 25 G | In distribution |
| EUS-19-0-CS1 | Needle Gauge 19 G | In distribution |
| EUS-25-0 | Needle Gauge 25 G | In distribution |
| EUS-22-0-CS1 | Needle Gauge 22 G | In distribution |
| EUS-19-0-CS2 | Needle Gauge 19 G | In distribution |
| EUS-22-0-CS2 | Needle Gauge 22 G | In distribution |
| EUS-25-0-CS1 | Needle Gauge 25 G | In distribution |
| EUS-22-0-N | Needle Gauge 22 G | In distribution |
| EUS-19-0 | Needle Gauge 19 G | In distribution |
| EUS-25-0-CS2 | Needle Gauge 25 G | In distribution |
| EUS-22-0 | Needle Gauge 22 G | In distribution |
| EUS-19-0-N | Needle Gauge 19 G | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Pentax | Hoya Corporation | 22 |
| Areus(TM) Adapt Endoscopic Ultrasound Aspiration Needle(FNA) | Micro-Tech (Nanjing) Co., Ltd. | 6 |
| 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 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 | Closed |
|---|---|---|---|---|---|---|---|
| Micro-Tech (Nanjing) Co., Ltd. | 510(k) number | 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 |
| Micro-Tech (Nanjing) Co., Ltd. | 510(k) number | 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.