Pentax
Cartridge W/Lamp For EPK-1000 OL-X20
8manufacturers in China registered for this device type
5catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (4), Jiangsu (3), Shanghai (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Qisda Electronics (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 5 |
| Micro-Tech (Nanjing) Co., Ltd. | Nan Jing | Jiangsu | Contract manufacturer | 49 |
| Shenzhen Hugemed Medical Technical Development Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 22 |
| Scivita Medical Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 19 |
| Guangzhou RED Pine Medical Instrument Co., Ltd. | Guangzhou | Guangdong | Manufacturer | 8 |
| Zhuhai Pusen Medical Technology Co., Ltd. | Zhuhai | Guangdong | Manufacturer | 7 |
| Shanghai Seegen Photoelectric Technology Co., Ltd. | Shanghai | Shanghai | Manufacturer | 7 |
| Shenzhen Sophway Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 3 |
Record
| Listed by | Hoya Corporation, Bulgaria |
|---|---|
| FDA product code | FET |
| Device type | Endoscopic Video Imaging System/Component, Gastroenterology-Urology |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| Establishment | Manufacturer, Exporter |
| 510(k) | K934918 |
| Record published | 2017-04-07 |
| Record revised | 2025-04-07 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
| Distribution end date | 2024-09-30 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| OS-A50 | In distribution | |
| EPK-p(C) | In distribution | |
| EPK-1000 | In distribution | |
| OL-X20 | Withdrawn | |
| AE-P1 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Endocam | Richard Wolf Gmbh | 21 |
| Endoscopic Video Imaging System/Component, Gastroenterology-Urology | Karl Storz GmbH & Co. KG | 20 |
| Gimmi | Gimmi Gmbh | 9 |
| Image 1 | Karl Storz GmbH & Co. KG | 8 |
| Exalt™ | Boston Scientific Corporation | 8 |
| Conmed | ConMed Corporation | 7 |
| Video Adapter | Olympus Medical Systems Corp. | 6 |
| EleVision™ | Schölly Fiberoptic GmbH | 6 |
| Evis Exera Colonovideoscope | Olympus Medical Systems Corp. | 5 |
| Water Resistant CAP | Olympus Medical Systems Corp. | 5 |
| CystoView™ | Verathon Medical (Canada) ULC | 5 |
| Riwo | Richard Wolf Gmbh | 5 |
Showing 12 of 105. All products under Endoscopic Video Imaging System/Component, 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.