BIG-TIP™
225 catalogue numbers from BTW 2040B, listed by RF Medical Co., Ltd., South Korea, under Electrosurgical, Cutting & Coagulation & Accessories. 65 manufacturers in China are registered for this product code.
65manufacturers in China registered for this device type
225catalogue numbers in this listing
4510(k) clearances naming this product code
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 | RF Medical Co., Ltd., South Korea |
|---|---|
| FDA product code | GEI |
| Device type | Electrosurgical, Cutting & Coagulation & Accessories |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4400 |
| Establishment | Complaint-file establishment, Manufacturer |
| 510(k) | K221277 |
| Record published | 2025-09-05 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | expiry date, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| BTW 2040B | In distribution | |
| BT 1035OB | In distribution | |
| CWT 3525B | In distribution | |
| BTM 3035QB | In distribution | |
| BT 0625PB | In distribution | |
| BTW 2020B | In distribution | |
| BTM 3005QB | In distribution | |
| CWT 2535RB | In distribution | |
| BT 0640PB | In distribution | |
| BTM 2010RB | In distribution | |
| BTM 3035RB | In distribution | |
| CWT 2040B | In distribution | |
| BTM 3515QB | In distribution | |
| BT 0610B | In distribution | |
| BT 0630PB | In distribution | |
| CWT 3505RB | In distribution | |
| BTM 3520RB | In distribution | |
| BT 2510B | In distribution | |
| BTM 2540RB | In distribution | |
| BT 2540B | In distribution | |
| BTM 2530RB | In distribution | |
| BT 0607PB | In distribution | |
| BTW 2030B | In distribution | |
| CWT 3535B | In distribution | |
| BT 1030B | In distribution | |
| BT 2040B | In distribution | |
| BTM 2515RB | In distribution | |
| BTM 2505QB | In distribution | |
| CWT 2020RB | In distribution | |
| BT+ 2505B | In distribution | |
| BT+ 2535B | In distribution | |
| CWT 2025B | In distribution | |
| BTM 2020QB | In distribution | |
| CWT 2520B | In distribution | |
| BTM 2030RB | In distribution | |
| CWT 2530B | In distribution | |
| BT 1020OB | In distribution | |
| BT+ 2005B | In distribution | |
| BTM 2025RB | In distribution | |
| CWT 1505B | In distribution | |
| BTM 3040QB | In distribution | |
| BTM 3510QB | In distribution | |
| CWT 3510RB | In distribution | |
| CWT 2020B | In distribution | |
| CWT 3530B | In distribution | |
| BTM 3040RB | In distribution | |
| BT 1010OB | In distribution | |
| CWT 1510B | In distribution | |
| BT 1020B | In distribution | |
| CWT 2040RB | In distribution | |
| CWT 2015RB | In distribution | |
| BTM 2020RB | In distribution | |
| CWT 3515RB | In distribution | |
| BTM 2525RB | In distribution | |
| BT 0610PB | In distribution | |
| BT 1525B | In distribution | |
| BT 1025OB | In distribution | |
| BTM 3515RB | In distribution | |
| BT+ 2035B | In distribution | |
| BTM 3525RB | In distribution | |
| BT+ 1540B | In distribution | |
| BTM 3540QB | In distribution | |
| CWT 2025RB | In distribution | |
| CWT 2505B | In distribution | |
| CWT 3510B | In distribution | |
| CWT 2005B | In distribution | |
| BTM 2530QB | In distribution | |
| BTM 2005RB | In distribution | |
| BT 1040B | In distribution | |
| BT 1040OB | In distribution | |
| BT+1505B | In distribution | |
| JET 1020B | In distribution | |
| BTM 3025QB | In distribution | |
| BTW 1540B | In distribution | |
| BT 2535B | In distribution | |
| BT+ 2510B | In distribution | |
| BT 1510B | In distribution | |
| BTM 2035RB | In distribution | |
| BT 2520B | In distribution | |
| CWT 3515B | In distribution | |
| BTM 2010QB | In distribution | |
| BT+ 1520B | In distribution | |
| CWT 1510RB | In distribution | |
| CWT 2030RB | In distribution | |
| BT 0605B | In distribution | |
| BTM 3015RB | In distribution | |
| BT 1505B | In distribution | |
| CWT 1540B | In distribution | |
| CWT 2035B | In distribution | |
| CWT 3530RB | In distribution | |
| CWT 2015B | In distribution | |
| BT 2025B | In distribution | |
| BTM 3010QB | In distribution | |
| BT 0620B | In distribution | |
| CWT 2510RB | In distribution | |
| BT 1520B | In distribution | |
| BT 0640B | In distribution | |
| BTM 2520RB | In distribution | |
| CWT 3520B | In distribution | |
| BTM 2025QB | In distribution | |
| BT+ 2520B | In distribution | |
| BT 1015OB | In distribution | |
| BTM 2540QB | In distribution | |
| BT 1515B | In distribution | |
| CWT 1530B | In distribution | |
| CWT 2005RB | In distribution | |
| BTM 2515QB | In distribution | |
| CWT 2540B | In distribution | |
| BTW 2015B | In distribution | |
| BTM 3530QB | In distribution | |
| BT 2530B | In distribution | |
| CWT 2510B | In distribution | |
| CWT 1535RB | In distribution | |
| BT+ 2515B | In distribution | |
| BT 0630B | In distribution | |
| BT+1530B | In distribution | |
| BT 2030B | In distribution | |
| BT 2015B | In distribution | |
| BTM 3020RB | In distribution | |
| BT+ 2040B | In distribution | |
| BTM 3520QB | In distribution | |
| BT 0615B | In distribution | |
| CWT 3540B | In distribution | |
| CWT 1525RB | In distribution | |
| BTM 3525QB | In distribution | |
| BT 2525B | In distribution | |
| BTM 2510QB | In distribution | |
| BT+ 2540B | In distribution | |
| BTW 2010B | In distribution | |
| BT 1535B | In distribution | |
| BTW 2005B | In distribution | |
| BT 0635PB | In distribution | |
| CWT 1540RB | In distribution | |
| CWT 2035RB | In distribution | |
| BTW 1520B | In distribution | |
| CWT 1525B | In distribution | |
| CWT 1535B | In distribution | |
| BT 1005OB | In distribution | |
| BTM 2535QB | In distribution | |
| BT+ 2525B | In distribution | |
| BTM 2040QB | In distribution | |
| BT 1005B | In distribution | |
| BTM 2015RB | In distribution | |
| CWT 1515RB | In distribution | |
| BTM 3535RB | In distribution | |
| BTW 1505B | In distribution | |
| CWT 2530RB | In distribution | |
| BT 1015B | In distribution | |
| BT 1030OB | In distribution | |
| BT+ 2010B | In distribution | |
| BT+ 1535B | In distribution | |
| BT 2515B | In distribution | |
| CWT 1530RB | In distribution | |
| CWT 3540RB | In distribution | |
| BT 2035B | In distribution | |
| BTM 3505RB | In distribution | |
| BTM 3030RB | In distribution | |
| BTM 2525QB | In distribution | |
| BTM 2535RB | In distribution | |
| BTM 2040RB | In distribution | |
| BT 0635B | In distribution | |
| BT+ 1510B | In distribution | |
| BTW 2035B | In distribution | |
| BTM 3005RB | In distribution | |
| BT 0605PB | In distribution | |
| BTW 1535B | In distribution | |
| CWT 2540RB | In distribution | |
| BT 0615PB | In distribution | |
| BT 2505B | In distribution | |
| BT 1540B | In distribution | |
| BTW 1530B | In distribution | |
| CWT 3505B | In distribution | |
| BTM 2505RB | In distribution | |
| BTW 1510B | In distribution | |
| CWT 1515B | In distribution | |
| BT+ 2530B | In distribution | |
| BTM 3025RB | In distribution | |
| BTM 3530RB | In distribution | |
| BT+ 2020B | In distribution | |
| BTM 3510RB | In distribution | |
| BT 2010B | In distribution | |
| BTM 2520QB | In distribution | |
| BT+2030B | In distribution | |
| CWT 2010RB | In distribution | |
| BTW 1525B | In distribution | |
| CWT 3525RB | In distribution | |
| CWT 2515B | In distribution | |
| CWT 1520B | In distribution | |
| CWT 2535B | In distribution | |
| BT 1010B | In distribution | |
| BTM 3020QB | In distribution | |
| BTM 3540RB | In distribution | |
| BT+ 2025B | In distribution | |
| CWT 2525RB | In distribution | |
| BT 0620PB | In distribution | |
| BTW 1515B | In distribution | |
| BTM 2035QB | In distribution | |
| BTW 2025B | In distribution | |
| CWT 1520RB | In distribution | |
| CWT 3520RB | In distribution | |
| BT 1530B | In distribution | |
| BTM 3505QB | In distribution | |
| BTM 2005QB | In distribution | |
| BT 2020B | In distribution | |
| BT 0625B | In distribution | |
| CWT 2010B | In distribution | |
| BT+ 1515B | In distribution | |
| CWT 1505RB | In distribution | |
| BT 1035B | In distribution | |
| CWT 2520RB | In distribution | |
| CWT 2030B | In distribution | |
| CWT 2515RB | In distribution | |
| BTM 3015QB | In distribution | |
| BTM 3010RB | In distribution | |
| BTM 2510RB | In distribution | |
| BTM 2015QB | In distribution | |
| BT 1025B | In distribution | |
| BT 2005B | In distribution | |
| BTM 2030QB | In distribution | |
| CWT 2505RB | In distribution | |
| CWT 3535RB | In distribution | |
| BTM 3030QB | In distribution | |
| BTM 3535QB | In distribution | |
| BT+ 2015B | In distribution | |
| BT+ 1525B | 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 |
|---|---|
| K232763 | 2023-10-04 |
| K221277 | 2022-09-02 |
| K193355 | 2020-08-03 |
| K180999 | 2018-12-11 |
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.