ADAPTER-1
Catalogue number 161822, listed by AKTORmed GmbH, Germany, under System, Surgical, Computer Controlled Instrument. 4 manufacturers in China are registered for this product code.
4manufacturers in China registered for this device type
1catalogue number
2510(k) clearances naming this product code
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 | AKTORmed GmbH, Germany |
|---|---|
| FDA product code | NAY |
| Device type | System, Surgical, Computer Controlled Instrument |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| Establishment | Manufacturer, Exporter |
| Record published | 2021-04-29 |
| Record revised | 2026-03-19 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 161822 | 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K200473 | 2020-12-22 |
| K171947 | 2018-09-21 |
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.