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Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device
1manufacturer
3catalogue numbers in this listing
8510(k) clearances naming this product 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 | Boston Scientific Corporation, United States |
|---|---|
| FDA product code | ODG |
| Device type | Endoscopic Ultrasound System, Gastroenterology-Urology |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2017-03-01 |
| Record revised | 2019-07-12 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 5 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| M00555580 | 19 ga Diameter | In distribution |
| M00555560 | 0.52 mm Diameter | In distribution |
| M00555540 | 0.72 mm Diameter | 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 |
| 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 |
| 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 |
|---|---|
| K260428 | 2026-06-17 |
| K223616 | 2022-12-30 |
| K173184 | 2017-10-27 |
| K163058 | 2017-01-30 |
| K160845 | 2016-05-03 |
| K133312 | 2014-01-03 |
| K112198 | 2011-09-14 |
| K110030 | 2011-01-12 |
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.