Dyonics RF, Cross
Dyonics RF-S Cross 50 DEG
65manufacturers in China registered for this device type
1catalogue number
10510(k) clearances naming this product code
11recalls on this 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 | Smith & Nephew, Inc., United States |
|---|---|
| FDA product code | GEI |
| Device type | Electrosurgical, Cutting & Coagulation & Accessories |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4400 |
| Establishment | Contract manufacturer, Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K093165 |
| Record published | 2015-09-21 |
| Record revised | 2023-09-07 (version 5) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 72202140 | 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 |
|---|---|
| K083528 | 2009-01-28 |
| K073466 | 2008-02-22 |
| K050898 | 2005-05-25 |
| K041328 | 2004-07-27 |
| K033981 | 2004-02-25 |
| K031675 | 2003-06-20 |
| K031371 | 2003-05-23 |
| K012314 | 2002-02-01 |
| K994365 | 2000-03-13 |
| K990723 | 1999-10-05 |
Recalls
2 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2012-07-14 | Class II | Error in labeling | Devices labeled with an expiry period of 48 months instead of 36 months; an additional 12 months for which product and package reliability has not been validated. | 340 units | 2021-03-22 |
| 2012-07-14 | Class II | Error in labeling | Device labeled with an expiry period of 48 months instead of 36 months; an additional 12 months for which product and package reliability has not been validated. | 108 units | 2021-03-22 |
| 2011-11-07 | Not classified | Process control | Manufacturing issue: The distal tip of the outer sheath (return electrode) may detach and become loose in the joint during use. | 1743 units | 2016-02-22 |
| 2006-06-19 | Not classified | Other | Sterility seal of the package tray may have gaps/voids compromising the sterility of the device. | 693 boxes/Expanded 534 units | 2008-01-10 |
| 2006-06-19 | Not classified | Other | Sterility seal of the package tray may have gaps/voids compromising the sterility of the device. | 445 boxes/Expanded 348 units | 2008-01-10 |
| 2006-06-19 | Not classified | Other | The sterility seal of the package trays may have incomplete seals compromising the sterility of the device | 1175 units/Expanded 1674 units | 2008-01-10 |
| 2006-06-19 | Not classified | Other | Sterility seal of the package tray may have gaps/voids compromising the sterility of the device. | 1833 boxes/Expanded Recall 1851 units | 2008-01-10 |
| 2006-06-19 | Not classified | Other | Sterility seal of the package tray may have gaps/voids compromising the sterility of the device. | 1026 boxes/Expanded 891 units | 2008-01-10 |
| 2006-06-19 | Not classified | Other | The sterility seal of the package trays may have incomplete seals compromising the sterility of the device | 2856 units/Expanded 207 units | 2008-01-10 |
| 2006-06-19 | Not classified | Other | The sterility seal of the package trays may have incomplete seals compromising the sterility of the device | 8631 units/Expanded1071 units | 2008-01-10 |
| 2006-06-19 | Not classified | Other | The sterility seal of the package trays may have incomplete seals compromising the sterility of the device | 5553 units/Expanded 1488 units | 2008-01-10 |
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.