Endoeye Flex Deflectable Videoscope
LTF-S190-10 Endoeye Flex 10 Videoscope
21manufacturers in China registered for this device type
1catalogue number
3510(k) clearances naming this product code
Who Else Makes It
Concentrated in Guangdong (10), Jiangsu (3), Shanghai (3). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Guangdong MacroLux Medical Technology Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 9 |
| Ningbo Wise Optomech Technology Corporation | Ningbo | Zhejiang | Contract manufacturer | 4 |
| Shenzhen Hugemed Medical Technical Development Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 22 |
| Suzhou Prosteri Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 20 |
| Suzhou Virgil Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 20 |
| Scivita Medical Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 19 |
| Macrolux Medical Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 9 |
| Guangzhou RED Pine Medical Instrument Co., Ltd. | Guangzhou | Guangdong | Manufacturer | 8 |
| Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. | Cixi | Zhejiang | Manufacturer | 8 |
| Zhuhai Pusen Medical Technology Co., Ltd. | Zhuhai | Guangdong | Manufacturer | 7 |
| Shanghai Seegen Photoelectric Technology Co., Ltd. | Shanghai | Shanghai | Manufacturer | 7 |
| Hunan Endoso Life Technology Co., Ltd. | Xiangtan | Hunan | Manufacturer | 7 |
Showing 12 of 21. All 21 manufacturers in China registered for Ureteroscope And Accessories, Flexible/Rigid
Record
| Listed by | Olympus Medical Systems Corp., Japan |
|---|---|
| FDA product code | FGB |
| Device type | Ureteroscope And Accessories, Flexible/Rigid |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| Establishment | Specification developer, Manufacturer, Exporter |
| Record published | 2016-09-21 |
| Record revised | 2025-10-06 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization, Ethylene Oxide |
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| OLYMPUS LTF-S190-10 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Ureteroscope And Accessories, Flexible/Rigid | Karl Storz GmbH & Co. KG | 36 |
| SemiFlex Scope | Maxiflex, LLC | 33 |
| E-Line | Richard Wolf Gmbh | 28 |
| Olympus | Olympus Winter & IBE Gmbh | 28 |
| Uscope | Zhuhai Pusen Medical Technology Co., Ltd. | 23 |
| WiScope® | OTU Medical Inc | 16 |
| Redpine | Guangzhou RED Pine Medical Instrument Co., Ltd. | 16 |
| LithoVue | Boston Scientific Corporation | 15 |
| Single-use Flexible Ureteroscope | Hunan Vathin Medical Instrument Co., Ltd. | 14 |
| Dornier MedTech | Dornier Medtech America, Inc. | 12 |
| Innovex | Shanghai AnQing Medical Instrument Co., Ltd. | 12 |
| Single Use Video Ureteroscope Direct In-Scope Suction | Zhuhai Pusen Medical Technology Co., Ltd. | 12 |
Showing 12 of 75. All products under Ureteroscope And Accessories, Flexible/Rigid
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K181451 | 2019-01-16 |
| K172246 | 2018-03-30 |
| K172298 | 2018-03-29 |
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Olympus Corporation of the Americas | UDI-DI | 2023-11-20 | Class II | Labeling Change Control | Instructions for Use-User Deviations related to the reprocessing of the videoscope detailed in the Reprocessing Manual Instructions. The steps are required for the proper reprocessing of these videoscopes | 271 units US |
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.