Pentax Medical
PENTAX Medical Ultrasound Upper GI Video Scope EG38-J10UT (Made in Malaysia)
1manufacturer
6catalogue numbers in this listing
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 | Hoya Corporation, Bulgaria |
|---|---|
| FDA product code | ODG |
| Device type | Endoscopic Ultrasound System, Gastroenterology-Urology |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| Establishment | Manufacturer, Exporter |
| 510(k) | K200090 |
| Record published | 2021-03-02 |
| Record revised | 2025-04-03 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | High-level Disinfectant, Liquid Chemical |
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Distribution end date | 2024-10-10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| EG38-J10UT | In distribution | |
| EG38-J10UT | In distribution | |
| EG34-J10U | In distribution | |
| EG36-J10UR | In distribution | |
| EG34-J10U | Withdrawn | |
| EG36-J10UR | Withdrawn |
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 |
| 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
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.