Slide-ON®
Sheath 335401 10PK CHL VSI ENT2000/PX10S
7manufacturers in China registered for this device type
29catalogue 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 | Medtronic Xomed, 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, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K012543 |
| Record published | 2016-04-23 |
| Record revised | 2024-03-06 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Distribution end date | 2023-12-06 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 334401 | 10 | In distribution | |
| 335401 | 10 | In distribution | |
| 336401 | 10 | In distribution | |
| 445601 | 10 | In distribution | |
| 334301 | 10 | In distribution | |
| 444401 | 10 | In distribution | |
| 225501 | 20 | In distribution | |
| 332401 | 10 | In distribution | |
| 226401 | 20 | In distribution | |
| 224101 | 20 | Withdrawn | |
| 225301 | 20 | Withdrawn | |
| 224501 | 20 | Withdrawn | |
| 445101 | 10 | Withdrawn | |
| 224301 | 20 | Withdrawn | |
| 225401 | 20 | Withdrawn | |
| 446301 | 10 | Withdrawn | |
| 336301 | 10 | Withdrawn | |
| 335201 | 10 | Withdrawn | |
| 222401 | 20 | Withdrawn | |
| 224401 | 20 | Withdrawn | |
| 225101 | 20 | Withdrawn | |
| 222101 | 20 | Withdrawn | |
| 445401 | 10 | Withdrawn | |
| 335301 | 10 | Withdrawn | |
| 442401 | 10 | Withdrawn | |
| 226101 | 20 | Withdrawn | |
| 226301 | 20 | Withdrawn | |
| 444301 | 10 | Withdrawn | |
| 445301 | 10 | 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® 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 |
|---|---|
| K173855 | 2018-04-20 |
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.