Cool-Tip
RFA High-Power Patient Return Electrode Extension Cable
65manufacturers in China registered for this device type
27catalogue numbers in this listing
1510(k) clearance
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 | Covidien LP, United States |
|---|---|
| FDA product code | GEI |
| Device type | Electrosurgical, Cutting & Coagulation & Accessories |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4400 |
| 510(k) | K973297 |
| Record published | 2016-09-24 |
| Record revised | 2025-06-24 (version 10) |
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, manufacturing date, serial number |
| Storage | Handling environment humidity 25 to 85 % RH; Storage environment temperature 50 to 104 °F; Handling environment temperature -29 to 149 °F; Storage environment humidity 30 to 75 % RH; Special storage condition: Keep dry |
| Packaging | Case of 10, case of 25 |
| Sizes | Length 10 to 25 cm |
| Distribution end date | 2025-06-30 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ACT2530 | tip exposure,3,Centimeter; | In distribution |
| ACT1020 | Length 10 cm | In distribution |
| SWCT1530 | Length 15 cm | In distribution |
| ACT2020 | tip exposure,2,Centimeter; | In distribution |
| ACTC1025 | Length 10 cm | In distribution |
| ACT1530 | tip exposure,3,Centimeter; | In distribution |
| SWCT1540 | exposure,4,Centimeter; | In distribution |
| ACTC1525 | Length 15 cm | In distribution |
| ACT1510 | Length 15 cm | In distribution |
| SWCT15303 | exposure,3,Centimeter; | In distribution |
| CTRF 117ZD | In distribution | |
| DGP-HP | In distribution | |
| SWCT25303 | Length 25 cm | In distribution |
| SWCT2530 | Length 25 cm | In distribution |
| ACT2030 | Length 20 cm | In distribution |
| ACT1520 | Length 15 cm | In distribution |
| ACT1507 | Length 14.4 cm | In distribution |
| ACT1030 | Length 10 cm | In distribution |
| SWCT2540 | exposure,4,Centimeter; | In distribution |
| ACTC2025 | tip exposure,2.5,Centimeter; | In distribution |
| CTSW Control ZD | In distribution | |
| CTRF 220 | Withdrawn | |
| CTRF 100 | Withdrawn | |
| CTRF 117ZE | Withdrawn | |
| CTRF 117 | Withdrawn | |
| DGP-HP-EXT | Withdrawn | |
| CTSW Control | 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 |
|---|---|
| K091223 | 2009-09-11 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Covidien | 510(k) number | 2012-08-01 | Class II | Process control | Covidien is conducting a recall of various production lots of DGHP RFA High Power single use grounding pads and Cool-tip RFA Electrode Kits due to the potential for foil degradation on the DGP-HP single use grounding pad which may result in | 184,934 units | 2013-09-06 |
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.