Colibri micro-ENT Scope
The Colibri micro-ENT scope provides a view inside the ear, airways, nose and sinus cavities during diagnostic and therapeutic endoscopy. The user steers the single-use scope through the…
The Colibri micro-ENT scope provides a view inside the ear, airways, nose and sinus cavities during diagnostic and therapeutic endoscopy. The user steers the single-use scope through the anatomy to inspect the area of interest.
A distal CMOS image sensor captures the view, with an LED providing illumination. An add-on working channel permits suction. The scope’s cable connects to a separate console that receives the images and displays them on a tablet-based screen.
Listed Item
Colibri micro ENT scope is intended to visualize the internal cavities of the ear, airways, nose and sinus cavities during diagnostic and therapeutic endoscope procedures.
Disposable Assembly
The handle and attachment cable are integrated into the single-use endoscope. The scope is supplied sterile after ethylene oxide sterilization, with these patient-procedure components discarded after use.
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 | 3NT Medical Ltd., Israel |
|---|---|
| FDA product code | EOB |
| Device type | Nasopharyngoscope (Flexible Or Rigid) |
| Device class | Class 2 |
| Regulation | 21 CFR 874.4760 |
| Establishment | Complaint-file establishment |
| 510(k) | K192305 |
| Record published | 2023-12-31 |
| Record revised | 2026-07-31 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | 5-pack of 5, 10 pack of 10, 10pack of 10 |
| Sizes | Angle 20 ° |
| Distribution end date | 2026-07-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ERW-0200 | Angle 20 ° | Withdrawn |
| ERW-0100 | Withdrawn |
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 |
|---|---|
| K202727 | 2021-07-23 |
| K192305 | 2020-02-27 |
| K162916 | 2017-02-24 |
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.