Thunderbeat II Shears With Ultrasonic Mode, 5mm, 45cm
The Thunderbeat II Shears with Ultrasonic Mode are hand instruments used in open, laparoscopic and endoscopic surgery to cut, seal, coagulate, grasp and dissect tissue. The 45 cm model…
The Thunderbeat II Shears with Ultrasonic Mode are hand instruments used in open, laparoscopic and endoscopic surgery to cut, seal, coagulate, grasp and dissect tissue. The 45 cm model TB2-0545FC operates with a compatible ultrasonic bipolar generator and transducer.
Seal and Cut or Seal mode supports vessels up to 7 mm in diameter, while Ultrasonic mode is limited to vessels up to 3 mm. Tissue bundles and lymphatics are also included within the indicated surgical uses.
System Configuration
The instrument is used with the TD-410 reusable cordless transducer and a USG-410 generator configured for Thunderbeat II compatibility. The hand 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 | Olympus Medical Systems Corp., Japan |
|---|---|
| FDA product code | GEI |
| Device type | Electrosurgical, Cutting & Coagulation & Accessories |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4400 |
| Establishment | Specification developer, Manufacturer, Exporter |
| 510(k) | K252150 |
| Record published | 2025-12-04 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| TB2-0545FC | 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 |
|---|---|
| K254056 | 2026-07-01 |
| K252150 | 2025-10-07 |
| K192103 | 2020-05-11 |
| K180575 | 2018-07-12 |
| K172610 | 2018-04-17 |
| K151743 | 2016-02-26 |
| K132703 | 2014-05-19 |
| K111202 | 2012-01-20 |
Recalls Naming This Product
4 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Olympus Corporation of the Americas | 510(k) number | 2026-03-23 | Class II | Device Design | Potential for detachment of a distal tip component of the device during use. | 830 units |
| Olympus Corporation of the Americas | 510(k) number | 2026-03-23 | Class II | Device Design | Potential for detachment of a distal tip component of the device during use. | 365 units |
| Olympus Corporation of the Americas | 510(k) number | 2026-03-23 | Class II | Device Design | Potential for detachment of a distal tip component of the device during use. | 3,360 units |
| Olympus Corporation of the Americas | 510(k) number | 2026-03-23 | Class II | Device Design | Potential for detachment of a distal tip component of the device during use. | 490 units |
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.