Sinuscope
32 catalogue numbers from 161 271 765, listed by Sopro-Comeg GmbH, Germany, under Nasopharyngoscope (Flexible Or Rigid). 7 manufacturers in China are registered for this product code.
7manufacturers in China registered for this device type
32catalogue numbers in this listing
1510(k) clearance
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 | Sopro-Comeg GmbH, Germany |
|---|---|
| FDA product code | EOB |
| Device type | Nasopharyngoscope (Flexible Or Rigid) |
| Device class | Class 2 |
| Regulation | 21 CFR 874.4760 |
| 510(k) | K944656 |
| Record published | 2018-03-20 |
| Record revised | 2023-11-17 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Label carries | lot or batch number, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 161 271 765 | In distribution | |
| 161 401 815 | In distribution | |
| 161 271 785BC001 | In distribution | |
| 161 401 815BC001 | In distribution | |
| 161 401 813 | In distribution | |
| 161 401 825 | In distribution | |
| 161 271 762BC001 | In distribution | |
| 161 271 780 | In distribution | |
| 161 401 820BC001 | In distribution | |
| 161 271 762 | In distribution | |
| 161 401 800BC001 | In distribution | |
| 161 271 765BC001 | In distribution | |
| 161 401 800 | In distribution | |
| 161 401 810BC001 | In distribution | |
| 161 401 805 | In distribution | |
| 161 401 803BC001 | In distribution | |
| 161 401 812 | In distribution | |
| 161 401 813BC001 | In distribution | |
| 161 401 802BC001 | In distribution | |
| 161 401 820 | In distribution | |
| 161 401 825BC001 | In distribution | |
| 161 401 805BC001 | In distribution | |
| 161 401 810 | In distribution | |
| 161 401 812BC001 | In distribution | |
| 161 401 802 | In distribution | |
| 161 271 782 | In distribution | |
| 161 401 803 | In distribution | |
| 161 271 782BC001 | In distribution | |
| 161 271 760 | In distribution | |
| 161 271 785 | In distribution | |
| 161 271 780BC001 | In distribution | |
| 161 271 760BC001 | 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 |
| 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 |
| Prosidio | Prosidio LLC | 23 |
Showing 12 of 147. All products under Nasopharyngoscope (Flexible Or Rigid)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K153701 | 2016-09-09 |
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.