Pentax
A/W/B Channel Cleaning Adapter FOR EG-3630UR
1manufacturer
22catalogue 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) | K130206 |
| Record published | 2025-04-04 |
| Record revised | 2025-04-07 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | High-level Disinfectant, Ethylene Oxide, Sound Waves, Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Distribution end date | 2023-07-31 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| OE-A60 | 20 | In distribution | |
| OE-C5 | In distribution | ||
| OF-B171 | In distribution | ||
| OF-G1 | In distribution | ||
| OE-A51 | 20 | In distribution | |
| OF-A67 | 20 | In distribution | |
| CS6021SN | In distribution | ||
| OF-B172 | In distribution | ||
| OE-A56 | 20 | In distribution | |
| OF-B65 | Withdrawn | ||
| KW1818CS | Withdrawn | ||
| EG-3870UTK | Withdrawn | ||
| OF-B10 | Withdrawn | ||
| OF-B160 | Withdrawn | ||
| OF-BG3 | Withdrawn | ||
| OF-A67 | 20 | Withdrawn | |
| OE-A60 | 20 | Withdrawn | |
| OE-B5 | Withdrawn | ||
| OE-A51 | 20 | Withdrawn | |
| EG-3670URK | Withdrawn | ||
| EG-3270UK | Withdrawn | ||
| OF-B68 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| 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
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Pentax of America, Inc. | 510(k) number | 2017-05-23 | Class II | Error in labeling | Error in reprocessing instructions in Revisions 13 and 14 of IFU Z845, used with EG-3670URK and EG-3870UTK ultrasound gastroscopes. In the disinfection step, the IFU has a warning indicating the cleaning detergent solution should remain in | US: 116 units | 2020-05-21 |
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.