ArtiSeal Vessel Sealing System – ArtiSeal Instruments
ArtiSeal Instruments are bipolar electrosurgical tools for sealing and dividing vessels or tissue bundles during general surgery. They are used with the ArtiSeal Generator in minimally…
ArtiSeal Instruments are bipolar electrosurgical tools for sealing and dividing vessels or tissue bundles during general surgery. They are used with the ArtiSeal Generator in minimally invasive or open procedures and accommodate arteries and veins up to 7 mm.
The jaw closes through a grip lever, then receives radiofrequency energy through its electrodes for sealing. Hand movements articulate the jaw up, down, left and right, and rotation of the grip turns it through 360 degrees.
Listed Item
This device is an electrosurgical instrument intended to be used in conjunction with the ArtiSeal Generator. It delivers high-frequency (RF) energy to the human body. The current flowing into the tissue generates heat through bioimpedance, which is utilized for the ligation (sealing) and division (cutting) of vessels.
Instrument Supply
The instruments are supplied sterile for single use. A dedicated connector links them to the generator, which provides the RF energy used at the tissue interface.
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 2) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature 1 to 30 °C; Storage environment humidity 0 to 80 % RH |
| Sizes | Shaft length 41.5 cm; shaft length 345 mm; outer diameter 8 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AS01L | Shaft Length 41.5 cm | In distribution |
| AS01M | Shaft Length 345 mm | 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.