Peregrine Drivable ENT Scope
The Peregrine drivable ENT scope is a flexible endoscope for viewing the ear, airways, nose and sinus cavities during diagnostic or therapeutic procedures. The user steers the scope through…
The Peregrine drivable ENT scope is a flexible endoscope for viewing the ear, airways, nose and sinus cavities during diagnostic or therapeutic procedures. The user steers the scope through the anatomy to inspect the internal cavity.
A CMOS image sensor and illumination source at the distal end provide the view. A working channel allows irrigation and suction. The scope connects by cable to a separate video console, which receives its images and presents them on a tablet-based display.
Listed Item
The Peregrine Drivable ENT Scope is intended to visualize the internal cavities of the ear, airways, nose and sinus cavities during diagnostic and therapeutic endoscopy procedures.
Single-Use Assembly
The endoscope is supplied sterile for single use. Its handle and attachment cable are integrated into the disposable scope assembly.
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) | K202727 |
| Record published | 2023-01-31 |
| 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 | 10 pack of 10, 5 pack of 5 |
| Distribution end date | 2026-07-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SWY-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.