HandX
The HandX is intended to assist in the accurate control of HX laparoscopic Instruments including needle holder and grasper, for endoscopic manipulation of tissue, including grasping,…
The HandX is intended to assist in the accurate control of HX laparoscopic Instruments including needle holder and grasper, for endoscopic manipulation of tissue, including grasping, approximation, ligation, suturing, during laparoscopic surgical procedures. It is intended to be used by trained physicians in an operating room environment in accordance with its Instructions For Use.
Who Else Makes It
Concentrated in Guangdong (3), Jiangsu (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Alden Products Company | Shenzhen | Guangdong | Contract manufacturer | 24 |
| Dongguan Honfield Precision Parts Co., Ltd. | Zhangmutou, Dongguan | Guangdong | Contract manufacturer | 8 |
| Agibot Medtech (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 5 |
| Zhuhai Dipu Medical Technology Co., Ltd. | Zhuhai | Guangdong | Manufacturer | 3 |
Record
| Listed by | Human Xtensions, Ltd., Israel |
|---|---|
| FDA product code | NAY |
| Device type | System, Surgical, Computer Controlled Instrument |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| Record published | 2018-09-06 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Storage environment temperature -10 to 50 °C; Storage environment humidity 25 to 85 % RH |
| Packaging | Pack of 2 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 20-30-019-01 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Senhance | Asensus Surgical, Inc. | 147 |
| System, Surgical, Computer Controlled Instrument | Intuitive Surgical, Inc. | 106 |
| EndoWrist | Intuitive Surgical, Inc. | 68 |
| EndoWrist;daVinci Si | Intuitive Surgical, Inc. | 55 |
| EndoWrist SP | Intuitive Surgical, Inc. | 22 |
| Force Feedback | Intuitive Surgical, Inc. | 20 |
| Single-Site | Intuitive Surgical, Inc. | 14 |
| daVinci Si | Intuitive Surgical, Inc. | 9 |
| Single-Site; daVinci Si | Intuitive Surgical, Inc. | 8 |
| SureForm | Intuitive Surgical, Inc. | 6 |
| daVinci Xi | Intuitive Surgical, Inc. | 6 |
| daVinci 5 | Intuitive Surgical, Inc. | 5 |
Showing 12 of 62. All products under System, Surgical, Computer Controlled Instrument
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.