Precision S 4k
20 catalogue numbers from 0502-652-130, listed by Stryker GmbH, Switzerland, under Nasopharyngoscope (Flexible Or Rigid). 7 manufacturers in China are registered for this product code.
7manufacturers in China registered for this device type
20catalogue 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 | Stryker GmbH, Switzerland |
|---|---|
| FDA product code | EOB |
| Device type | Nasopharyngoscope (Flexible Or Rigid) |
| Device class | Class 2 |
| Regulation | 21 CFR 874.4760 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| Record published | 2019-09-30 |
| Record revised | 2023-11-17 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization, Hydrogen Peroxide |
| Label carries | serial number |
| Sizes | Length 125 to 180 mm; angle 0 to 70 ° |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 0502-652-130 | Length 170.0 mm | In distribution |
| 0502-655-030 | Diameter: 4.0 Millimeter | In distribution |
| 0502-652-045 | Diameter: 3.1 Millimeter | In distribution |
| 0502-655-010 | Angle 0.0 ° | In distribution |
| 0502-654-045 | Length 155.0 mm | In distribution |
| 0502-653-130 | Length 125.0 mm | In distribution |
| 0502-654-070 | Diameter: 4.0 Millimeter | In distribution |
| 0502-654-130 | Length 155.0 mm | In distribution |
| 0502-654-170 | Angle 70.0 ° | In distribution |
| 0502-652-030 | Angle 30.0 ° | In distribution |
| 0502-654-030 | Angle 30.0 ° | In distribution |
| 0502-654-145 | Length 155.0 mm | In distribution |
| 0502-652-170 | Length 170.0 mm | In distribution |
| 0502-652-145 | Diameter: 3.1 Millimeter | In distribution |
| 0502-652-070 | Angle 70.0 ° | In distribution |
| 0502-652-010 | Diameter: 3.1 Millimeter | In distribution |
| 0502-654-010 | Length 155.0 mm | In distribution |
| 0502-653-030 | Angle 30.0 ° | In distribution |
| 0502-653-010 | Length 125.0 mm | In distribution |
| 0502-655-130 | Diameter: 4.0 Millimeter | 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 |
|---|---|
| K191102 | 2019-09-06 |
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.