Endoeye Flex Deflectable Videoscope
The ENDOEYE FLEX LTF-S190-5 is a deflectable videoscope for endoscopy and surgery within the chest and abdomen, including female reproductive organs. It is used with compatible video…
The ENDOEYE FLEX LTF-S190-5 is a deflectable videoscope for endoscopy and surgery within the chest and abdomen, including female reproductive organs. It is used with compatible video processing, illumination, display and surgical equipment.
The scope has control, insertion and connector sections, with distal objective and light guide lenses providing the imaging view. Its forward viewing optical system has an 85 degree field of view.
Listed Item
LTF-S190-5 Endoeye Flex 5 HD Videoscope
Reuse and Preparation
The instrument is reusable and supplied nonsterile for healthcare facility use. Listed sterilization methods include ethylene oxide, autoclaving and specified hydrogen peroxide systems. The scope provides visualization while separate hand instruments or electrosurgical devices perform treatment.
Who Else Makes It
Concentrated in Zhejiang (3), Guangdong (3), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Modern Medical Equipment Manufacturing Ltd. | Heng Li, Dongguan | Guangdong | Contract manufacturer | 26 |
| Hangzhou Fushan Medical Appliance Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 44 |
| Modern Medical Equipment Manufacturing (Qing Yuan) Ltd | Qing Yuan | Guangdong | Contract manufacturer | 26 |
| Scivita Medical Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 19 |
| Global Medical Production Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 10 |
| Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. | Cixi | Zhejiang | Manufacturer | 8 |
| Guangdong Optomedic Technologies, Inc. | Foshan | Guangdong | Manufacturer | 7 |
Record
| Listed by | Olympus Medical Systems Corp., Japan |
|---|---|
| FDA product code | HET |
| Device type | Laparoscope, Gynecologic (And Accessories) |
| Device class | Class 2 |
| Regulation | 21 CFR 884.1720 |
| Establishment | Specification developer, Manufacturer, Exporter |
| 510(k) | K201832 |
| Record published | 2023-04-22 |
| Record revised | 2026-02-16 (version 9) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | High-level Disinfectant, Ethylene Oxide |
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| OLYMPUS LTF-S190-5 | In distribution | |
| OLYMPUS LTF-S190-5 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Endoplus | Endoplus | 448 |
| Integra® MicroFrance® | Integra Microfrance SAS | 273 |
| Symmetry Surgical® | Aspen Surgical Products, Inc. | 139 |
| Laparoscope, Gynecologic (And Accessories) | Karl Storz GmbH & Co. KG | 119 |
| Elmed | Elmed, Inc. | 96 |
| Olympus | Olympus Winter & IBE Gmbh | 71 |
| Core Dynamics | ConMed Corporation | 52 |
| Symmetry | Aspen Surgical Products, Inc. | 48 |
| DANmed | Dannoritzer Medizintechnik GmbH & Co. KG | 45 |
| Laparoscope, Gynecologic (And Accessories) | Richard Wolf Gmbh | 37 |
| Take-Apart | Karl Storz GmbH & Co. KG | 31 |
| Blueendo | Trokamed Gmbh | 28 |
Showing 12 of 396. All products under Laparoscope, Gynecologic (And Accessories)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K201832 | 2021-09-17 |
| K151011 | 2015-10-01 |
| K123365 | 2013-03-01 |
| K111425 | 2012-04-20 |
| K081173 | 2008-12-23 |
| K080948 | 2008-09-26 |
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 |
|---|---|---|---|---|---|---|
| Olympus Corporation of the Americas | 510(k) number | 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 | 1403 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.