Soloist™
Single Needle Electrode
65manufacturers in China registered for this device type
3catalogue numbers in this listing
15510(k) clearances naming this product code
16recalls 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 | Boston Scientific Corporation, United States |
|---|---|
| FDA product code | GEI |
| Device type | Electrosurgical, Cutting & Coagulation & Accessories |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4400 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2016-09-24 |
| Record revised | 2022-06-10 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| M001262510 | 3 m Effective Length | In distribution |
| M001262520 | 16.5 ga Diameter | In distribution |
| M001262500 | 1.57 mm Diameter | 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 |
|---|---|
| K140495 | 2014-04-17 |
| K113090 | 2012-03-15 |
| K092009 | 2009-11-06 |
| K060419 | 2006-03-13 |
| K053128 | 2005-11-30 |
| K050361 | 2005-03-14 |
| K040785 | 2004-04-28 |
| K040219 | 2004-02-24 |
| K040104 | 2004-02-18 |
| K032207 | 2003-08-20 |
| K023291 | 2002-10-17 |
| K013873 | 2002-07-11 |
| K021046 | 2002-04-16 |
| K010956 | 2001-04-13 |
| K981981 | 1998-09-03 |
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 |
|---|---|---|---|---|---|
| 2020-11-18 | Class II | Under Investigation by firm | Complaint trend regarding needle shaft gas leaks. | 740 units | |
| 2012-09-17 | Class II | Labeling Change Control | Leveen Standard and Leveen Coaccess Needle Electrode System, Directions for Use(DFU) in Portuguese, are incorrect. all other languages in the DFU are correct. Consignees in Brazil, Portugal,and Hong-Kong are being notified. | 19, 716 total all units | 2013-07-17 |
| 2012-03-02 | Not classified | Incorrect or no expiration date | Device found labeled with the incorrect expiration dates. The Soloist Single Needle Electrode has been qualified for a 3 year expiration date. Product manufactured between the dates of May 24, 2011 and November 8, 2011 has an incorrect expi | 682 (1555 used) | 2012-11-14 |
| 2009-07-06 | Not classified | Process control | The tines may detach from the core wire during use, which may result in bleeding or soft tissue trauma requiring medical intervention. | 2,774 | 2010-10-08 |
| 2009-07-06 | Not classified | Process control | The tines may detach from the core wire during use, which may result in bleeding or soft tissue trauma requiring medical intervention. | 347 | 2010-10-08 |
| 2008-04-30 | Not classified | Device Design | The cannula may become detached from its correct orientation inside the handle and may prevent retraction of the tines. | 2,307 | 2009-08-04 |
| 2008-04-30 | Not classified | Device Design | The cannula may become detached from its correct orientation inside the handle and may prevent retraction of the tines. | 7,460 | 2009-08-04 |
| 2008-04-30 | Not classified | Device Design | The cannula may become detached from its correct orientation inside the handle and may prevent retraction of the tines. | 1,356 | 2009-08-04 |
| 2008-04-30 | Not classified | Device Design | The cannula may become detached from its correct orientation inside the handle and may prevent retraction of the tines. | 9,843 | 2009-08-04 |
| 2007-10-01 | Not classified | Device Design | The cannula may become detached from its correct orientation inside the handle and may prevent retraction of the tines. | 15,604 of all products | 2008-09-16 |
| 2007-10-01 | Not classified | Device Design | The cannula may become detached from its correct orientation inside the handle and may prevent retraction of the tines. | 15,604 of all products | 2008-09-16 |
| 2007-10-01 | Not classified | Device Design | The cannula may become detached from its correct orientation inside the handle and may prevent retraction of the tines. | 15,604 of all products | 2008-09-16 |
| 2007-10-01 | Not classified | Device Design | The cannula may become detached from its correct orientation inside the handle and may prevent retraction of the tines. | 15,604 of all products | 2008-09-16 |
| 2005-07-29 | Not classified | Other | Firm has received complaints of extended ablation times, lack of roll-off and patient burns. | 2005-12-08 | |
| 2005-07-29 | Not classified | Other | Firm has received complaints of extended ablation times, lack of roll-off and patient burns. | 2005-12-08 | |
| 2005-07-15 | Not classified | Other | The distal tip may dislodge from the device during use and the firm has received complaints of electrical errors. | 115 | 2007-02-07 |
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.