Single-Use Flexible Rhinolaryngoscope
Single-Use Flexible Rhinolaryngoscope from Vathin examines the nasal cavity and upper respiratory tract in adults through a compatible Vathin display unit. Models with a working channel…
Single-Use Flexible Rhinolaryngoscope from Vathin examines the nasal cavity and upper respiratory tract in adults through a compatible Vathin display unit. Models with a working channel also allow treatment using compatible accessories.
Eight models vary in insertion diameter, working-channel availability and rotation function. Smaller versions have a 3.2 mm insertion width without an instrument channel; larger versions have a 5.0 mm insertion width and a 2.2 mm channel.
Viewing and Use
The scopes provide a 110-degree field of view and tip bending up to 210 degrees in either direction. They are intended for skilled medical staff trained in endoscopic techniques in hospitals or other qualified medical institutions.
Who Else Makes It
Concentrated in Guangdong (2), Jiangsu (2), Hunan (2).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Hugemed Medical Technical Development Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 22 |
| Suzhou Virgil Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 20 |
| Scivita Medical Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 19 |
| Hunan Vathin Medical Instrument Co., Ltd. | Xiangtan | Hunan | Manufacturer | 6 |
| Jiana Sterilization Technology (Changsha) Co., Ltd. | Changsha | Hunan | Contract manufacturer | 4 |
| Zhuhai Wesee Meditech Co., Ltd. | Zhuhai | Guangdong | Manufacturer | 2 |
| Liaoning Jrsd Commercial AND Trading Co., Ltd. | Shenyang | Liaoning | Manufacturer | 2 |
Record
| Listed by | Hunan Vathin Medical Instrument Co., Ltd., China |
|---|---|
| FDA product code | EOB |
| Device type | Nasopharyngoscope (Flexible Or Rigid) |
| Device class | Class 2 |
| Regulation | 21 CFR 874.4760 |
| Establishment | Manufacturer, Exporter |
| 510(k) | K221581 |
| Record published | 2023-02-17 |
| Record revised | 2026-04-15 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
| Packaging | Intermediate package of 2, shipping package of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| RL-E1801 | In distribution | |
| RL-E1E00 | In distribution | |
| RL-E1800 | In distribution | |
| RL-S1801 | In distribution | |
| RL-S1E00 | In distribution | |
| RL-S1800 | In distribution | |
| RL-S1E01 | In distribution | |
| RL-E1E01 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Nasopharyngoscope (Flexible Or Rigid) | Karl Storz GmbH & Co. KG | 174 |
| Hopkins | Karl Storz GmbH & Co. KG | 99 |
| Jedmed | Jedmed Instrument Company | 70 |
| Endo-Scrub® | Medtronic Xomed, Inc. | 51 |
| AED | National Advanced Endoscopy Devices, Inc. | 49 |
| Sinuscope | Sopro-Comeg GmbH | 32 |
| Sharpsite | Medtronic Xomed, Inc. | 30 |
| Slide-ON® | Medtronic Xomed, Inc. | 29 |
| Slide-ON® Endosheath® | Medtronic Xomed, Inc. | 28 |
| Sinuscope | Ecleris SRL | 27 |
| Nasopharyngoscope (Flexible Or Rigid) | Pentax of America, Inc. | 26 |
| Flex | Medrobotics Corporation | 24 |
Showing 12 of 147. All products under Nasopharyngoscope (Flexible Or Rigid)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K230536 | 2023-06-14 |
| K221581 | 2022-11-18 |
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.