Spinaut-V
SPINAUT-V is a steerable catheter used with a fiberoptic endoscope to observe the epidural space and deliver drugs indicated for epidural use. Its flexible shaft and steering handle guide…
SPINAUT-V is a steerable catheter used with a fiberoptic endoscope to observe the epidural space and deliver drugs indicated for epidural use. Its flexible shaft and steering handle guide the soft tip through the epidural space and surrounding tissue.
Ports provide access to the catheter lumen for the endoscope and fluid delivery. The catheter serves as the guided access component; the separate SPINAUT-S fiberoptic system supplies illumination and visualization.
Supply and Placement
SPINAUT-V is supplied sterile for single use. The separate SPINAUT-I introducer can establish a path for placement of the video-guided catheter or endoscope. Compatible equipment and the prescribed epidural medication determine the complete procedural setup.
Who Else Makes It
Concentrated in Shanghai (7), Jiangsu (6), Guangdong (5). 6 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Modern Medical Equipment Manufacturing Ltd. | Heng Li, Dongguan | Guangdong | Contract manufacturer | 26 |
| Dongguan BAO Kang Dian ZI KE JI Limited | Dongguan | Guangdong | Contract manufacturer | 24 |
| Sanmina | Kunshan | Jiangsu | Contract manufacturer | 15 |
| Peter’s Technology (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 9 |
| Jiangsu Shenli Medical Production Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 6 |
| PAN-International Precision Electronic Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 4 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Hangzhou Fushan Medical Appliance Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 44 |
| Arthrex (Shanghai) Co., Ltd. | Shanghai | Shanghai | Exporter | 38 |
| Goals Sterilization Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 26 |
Showing 12 of 21. All 21 manufacturers in China registered for Arthroscope
Record
| Listed by | Imedicom Co., Ltd., South Korea |
|---|---|
| FDA product code | HRX |
| Device type | Arthroscope |
| Device class | Class 2 |
| Regulation | 21 CFR 888.1100 |
| Establishment | Manufacturer, Exporter |
| 510(k) | K151268 |
| Record published | 2016-12-16 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| V3000 | In distribution | |
| V1000 | In distribution | |
| V2000 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Surgical Direct | Surgical Direct, Inc. | 299 |
| Arthroscope | Karl Storz GmbH & Co. KG | 278 |
| Conmed/Linvatec | Provision | 265 |
| Arthroscope | Smith & Nephew, Inc. | 255 |
| Medline | Medline Industries, Inc. | 205 |
| Arthroscope | Sterilmed, Inc. | 184 |
| Sustainable Technologies | Provision | 150 |
| Medline Renewal | Medline Industries, Inc. | 123 |
| Stryker | Provision | 113 |
| Arthrex® | Arthrex, Inc. | 109 |
| Arthrex | Provision | 109 |
| Eberle | Eberle GmbH & Co. KG | 92 |
Showing 12 of 567. All products under Arthroscope
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K182287 | 2019-04-06 |
| K151268 | 2016-03-16 |
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.