Artisential Bipolar Fenestrated Forceps
ArtiSential Bipolar Fenestrated Forceps grasps, dissects and coagulates soft tissue during laparoscopic surgery. It connects to a compatible electrosurgical generator that supplies…
ArtiSential Bipolar Fenestrated Forceps grasps, dissects and coagulates soft tissue during laparoscopic surgery. It connects to a compatible electrosurgical generator that supplies radiofrequency current to the electrode jaws.
A control ring opens and closes the jaws. Movement of the grip also bends the jaw section in multiple directions, and rotation of the grip rotates the working end.
Listed Item
Sterile Single-use Surgical Instrument used with electrosurgical generator intended to be used during lapaproscopic procedure for manipulation of tissue to cauterize, grasp and dissect tissue.
Articulating Instrument
The forceps has an 8 mm shaft, handle and generator connector. The jaw can articulate at least 80 degrees up, down, left or right and rotate through 360 degrees. A locking version is available alongside the nonlocking model. The instrument is supplied sterile for single use.
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) | K190909 |
| Record published | 2020-03-13 |
| Record revised | 2026-04-23 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment humidity up to 90 % RH; Storage environment temperature up to 50 °C |
| Sizes | Outer diameter 8 mm; shaft length 250 to 450 mm; shaft length 25 to 38 cm |
| Distribution end date | 2020-09-21 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ABF01L-L | Outer Diameter 8 mm | In distribution |
| ABF01S-FV | Outer Diameter 8 mm | In distribution |
| ABF01L-LV | Outer Diameter 8 mm | In distribution |
| ABF01S-LV | Outer Diameter 8 mm | In distribution |
| ABF01L-F | Outer Diameter 8 mm | In distribution |
| ABF01-LV | Outer Diameter 8 mm | In distribution |
| ABF01L-FV | Outer Diameter 8 mm | In distribution |
| ABF01-FV | Outer Diameter 8 mm | In distribution |
| ABF01-F | Withdrawn | |
| ABF01-L | Withdrawn |
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.