ArtiSeal Vessel Sealing System – ArtiSeal Generator
The ArtiSeal Generator supplies radiofrequency energy to compatible ArtiSeal surgical instruments for sealing vessels and tissue bundles in general surgery. It is the energy source portion…
The ArtiSeal Generator supplies radiofrequency energy to compatible ArtiSeal surgical instruments for sealing vessels and tissue bundles in general surgery. It is the energy source portion of the ArtiSeal Vessel Sealing System. The attached instrument carries the energy to its jaw electrodes at the tissue.
A dedicated connection socket links the instrument to the generator, and a touchscreen provides the interface. The generator automatically identifies the connected instrument and performs its safety and diagnostic checks. The instrument’s hand controls activate delivery of energy for the sealing step.
Listed Item
This device is an electrosurgical unit intended to generate high-frequency (RF) energy. When the energy is applied to the human body through the compatible ArtiSeal Instruments, the current generates heat through tissue bioimpedance, which is utilized for the ligation (sealing) and division (cutting) of vessels.
System Boundary
The generator works with disposable ArtiSeal hand instruments. Those instruments provide the tissue contacting jaws and mechanical controls used during minimally invasive or open procedures, while the generator provides the RF supply.
Who Else Makes It
Concentrated in Guangdong (24), Zhejiang (13), Shanghai (10). 23 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Hangzhou Kangji Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 27 |
| Modern Medical Equipment Manufacturing Ltd. | Heng Li, Dongguan | Guangdong | Contract manufacturer | 26 |
| Amphenol Alden Products Company | Shenzhen | Guangdong | Contract manufacturer | 24 |
| Hangzhou Endo Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 19 |
| Hong Qiangxing (Shen Zhen) Electronics Limited | Shenzhen | Guangdong | Contract manufacturer | 19 |
| Shenzhen MED-Link Electronics Tech Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 18 |
| Sanbor Medical Xiamen, Inc. | Xiamen | Fujian | Contract manufacturer | 16 |
| ATL Technology DG,Ltd. | Dongguan | Guangdong | Contract manufacturer | 14 |
| Jiangyin Sinbon Electronics Co Ltd | Jiangyin | Jiangsu | Contract manufacturer | 13 |
| Guangzhou Huada Biotechnology Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 9 |
Showing 12 of 65. All 65 manufacturers in China registered for Electrosurgical, Cutting & Coagulation & Accessories
Record
| Listed by | LivsMed Inc., South Korea |
|---|---|
| FDA product code | GEI |
| Device type | Electrosurgical, Cutting & Coagulation & Accessories |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4400 |
| Establishment | Manufacturer |
| 510(k) | K241138 |
| Record published | 2025-05-21 |
| Record revised | 2026-04-23 (version 3) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Storage environment temperature -10 to 60 °C; Storage environment humidity 15 to 90 % RH |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ASG-1000 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Surgical Direct | Surgical Direct, Inc. | 5,729 |
| Speedlock | National Advanced Endoscopy Devices, Inc. | 5,212 |
| Stingray Surgical Products | Stingray Surgical Products L.L.C. | 4,647 |
| Kirwan | Kirwan Surgical Products, LLC. | 1,901 |
| Millennium | Avalign Technologies, Inc. | 1,779 |
| DANmed | Dannoritzer Medizintechnik GmbH & Co. KG | 1,590 |
| Elmed | Elmed, Inc. | 1,519 |
| Symmetry Olsen | Aspen Surgical Products, Inc. | 1,219 |
| Guenter Bissinger Medizintechnik GmbH | Günter Bissinger Medizintechnik GmbH | 1,117 |
| Ambler Surgical | Ambler Surgical, LLC | 756 |
| V. Mueller | Steris Corporation | 661 |
| Aesculap | Aesculap AG | 544 |
Showing 12 of 2,922. All products under Electrosurgical, Cutting & Coagulation & Accessories
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K250126 | 2025-10-21 |
| K241138 | 2024-11-15 |
| K240657 | 2024-06-06 |
| K230498 | 2023-06-05 |
| K230539 | 2023-04-27 |
| K230499 | 2023-04-26 |
| K220384 | 2022-02-24 |
| K203580 | 2021-04-30 |
| K200875 | 2020-06-17 |
| K200501 | 2020-05-11 |
| K190909 | 2020-02-13 |
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.