Endo-Scrub®
Sheath 1912002 5PK 4MM/0DEG Storz Linvat
7manufacturers in China registered for this device type
51catalogue 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) | K982594 |
| Record published | 2016-04-22 |
| Record revised | 2024-05-22 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Sizes | Angle 0 to 70 °; lumen/inner diameter 2.7 to 4 mm; length 4 mm; width 4 mm |
| Distribution end date | 2026-03-25 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 1912050 | Angle 0.0 ° | 5 | In distribution |
| 197230FLA | Lumen/Inner Diameter 4.0 mm | 5 | In distribution |
| 1912030 | 5 | In distribution | |
| 197230CRA | Lumen/Inner Diameter 4.0 mm | 5 | In distribution |
| 1912023 | Lumen/Inner Diameter 2.7 mm | 5 | In distribution |
| 1912012 | Lumen/Inner Diameter 4.0 mm | 5 | In distribution |
| 1912014 | Lumen/Inner Diameter 4.0 mm | 5 | In distribution |
| 1912033 | Angle 0.0 ° | 5 | In distribution |
| 1912020 | Angle 70.0 ° | 5 | In distribution |
| 1912038 | Length 4.0 mm | 5 | In distribution |
| 1991015 | In distribution | ||
| 1912034 | Angle 30.0 ° | 5 | In distribution |
| 1912027 | Angle 30.0 ° | 5 | In distribution |
| 1912037 | Length 4.0 mm | 5 | In distribution |
| 1912000 | Length 4.0 mm | 5 | In distribution |
| 1912042 | Lumen/Inner Diameter 4.0 mm | 5 | In distribution |
| 1912019 | Lumen/Inner Diameter 4.0 mm | 5 | In distribution |
| 1912036 | Length 4.0 mm | 5 | In distribution |
| 1852000 | In distribution | ||
| 1912028 | Angle 30.0 ° | 5 | In distribution |
| 1912015 | Lumen/Inner Diameter 4.0 mm | 5 | In distribution |
| 197230BVA | Angle 30.0 ° | 5 | In distribution |
| 1912039 | Length 4.0 mm | 5 | In distribution |
| 1912004 | Lumen/Inner Diameter 4.0 mm | 5 | In distribution |
| 1852000 | In distribution | ||
| 1912008 | Lumen/Inner Diameter 4.0 mm | 5 | In distribution |
| 1912002 | Length 4.0 mm | 5 | In distribution |
| 1912010 | Lumen/Inner Diameter 4.0 mm | 5 | In distribution |
| 1912051 | Width 4.0 mm | 5 | In distribution |
| 1912031 | Lumen/Inner Diameter 4.0 mm | 5 | In distribution |
| 1912018 | Lumen/Inner Diameter 4.0 mm | 5 | In distribution |
| 1912013 | Angle 45.0 ° | 5 | In distribution |
| 1912040 | Length 4.0 mm | 5 | In distribution |
| 1912035 | Lumen/Inner Diameter 4.0 mm | 5 | In distribution |
| 197230CVA | Angle 70.0 ° | 5 | In distribution |
| 1912032 | Lumen/Inner Diameter 4.0 mm | 5 | In distribution |
| 1912043 | Angle 70.0 ° | 5 | In distribution |
| 1912041 | Lumen/Inner Diameter 4.0 mm | 5 | In distribution |
| 1912002 | Lumen/Inner Diameter 4.0 mm | 5 | Withdrawn |
| 1912040 | Angle 0.0 ° | 5 | Withdrawn |
| 1912050 | Lumen/Inner Diameter 4.0 mm | 5 | Withdrawn |
| 1912024 | Lumen/Inner Diameter 2.7 mm | 5 | Withdrawn |
| 1912024 | Angle 0.0 ° | 5 | Withdrawn |
| 1912023 | Lumen/Inner Diameter 2.7 mm | 5 | Withdrawn |
| 1912000 | Lumen/Inner Diameter 4.0 mm | 5 | Withdrawn |
| 1912008 | Lumen/Inner Diameter 4.0 mm | 5 | Withdrawn |
| 1912052 | Width 4.0 mm | 5 | Withdrawn |
| 1912004 | Lumen/Inner Diameter 4.0 mm | 5 | Withdrawn |
| 1912033 | Angle 0.0 ° | 5 | Withdrawn |
| 1912032 | Lumen/Inner Diameter 4.0 mm | 5 | Withdrawn |
| 1912038 | Length 4.0 mm | 5 | 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 |
| 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 |
| 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.