Sinuscope
Sinuscope 4.0mm, 45 Wide Angle
7manufacturers in China registered for this device type
14catalogue numbers in this listing
4510(k) clearances naming this product code
1recall
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 | Pentax of America, Inc., United States |
|---|---|
| FDA product code | EOB |
| Device type | Nasopharyngoscope (Flexible Or Rigid) |
| Device class | Class 2 |
| Regulation | 21 CFR 874.4760 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K944656 |
| Record published | 2017-04-06 |
| Record revised | 2023-11-17 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
| Sizes | Angle 0 to 70 °; outer diameter 2.7 to 4 mm |
| Distribution end date | 2017-07-24 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 8856 | Angle 70 ° | In distribution |
| 8852 | Angle 70 ° | In distribution |
| 8855 | Angle 45 ° | In distribution |
| 8850 | Angle 0 ° | In distribution |
| 8854 | Angle 30 ° | In distribution |
| 8851 | Angle 30 ° | In distribution |
| 8853-WA | Angle 0 ° | In distribution |
| 8855-WA | Angle 45 ° | In distribution |
| 8851-WA | Angle 30 ° | In distribution |
| 8850-WA | Angle 0 ° | In distribution |
| 8854-WA | Angle 30 ° | In distribution |
| 8856-WA | Angle 70 ° | In distribution |
| 8853 | Angle 0 ° | In distribution |
| 8853-R | Angle 0 ° | Withdrawn |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 |
|---|---|
| K220465 | 2022-11-16 |
| K183691 | 2019-06-12 |
| K182846 | 2019-01-09 |
| K162151 | 2017-04-20 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2016-04-06 | Class II | Device Design | Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope’s instrument channel. | 215 units | 2017-12-21 |
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.