VenaCure Evlt
NeverTouch Direct Procedure Kit, 1 Fiber w/ SMA 905 Connector
65manufacturers in China registered for this device type
1catalogue number
2510(k) clearances naming this product code
12recalls 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 | AngioDynamics, 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, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K130671 |
| Record published | 2016-09-20 |
| Record revised | 2019-02-12 (version 4) |
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 |
| Storage | Storage environment temperature up to 27 °C |
| Packaging | Box |
| Sizes | Needle gauge 21 G |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 11403101 | Needle Gauge 21 G | 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 |
|---|---|
| K080451 | 2008-07-03 |
| K080287 | 2008-07-03 |
Recalls
3 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 |
|---|---|---|---|---|---|
| 2019-10-02 | Class II | Under Investigation by firm | The devices are not labelled correctly. End users impacted by this issue may experience a procedural delay. | 30 | 2020-07-29 |
| 2014-12-19 | Class II | Other | Printed mark on the trocar intended to indicate a 5cm distance from the distal tip of the needle is actually located 4cm from the distal tip of the needle. | 43 | 2015-11-27 |
| 2013-06-11 | Class II | Packaging process control | The RITA Main Cable product contains the incorrect Instructions for Use. | 13 units | 2015-06-12 |
| 2010-08-30 | Not classified | Labeling False and Misleading | The labeling contains errors which result in the products being misbranded | 132 units | 2012-03-12 |
| 2010-08-30 | Not classified | Labeling False and Misleading | The labeling contains errors which result in the products being misbranded | 527 units | 2012-03-12 |
| 2007-04-03 | Not classified | Other | The product may have a cracked tray which can compromise the sterility of the product. | 751 devices | 2010-01-20 |
| 2007-04-03 | Not classified | Other | The product may have a cracked tray which can compromise the sterility of the product. | 2331 devices | 2010-01-20 |
| 2007-04-03 | Not classified | Other | The product may have a cracked tray which can compromise the sterility of the product. | 2021 devices | 2010-01-20 |
| 2006-05-02 | Not classified | Other | Misbranding; Product may have the wrong device handle which incorrectly identifies the product and also has incorrect deployment depth marker. | 21 units | 2008-02-05 |
| 2006-05-02 | Not classified | Other | Misbranding; Product may have the wrong device handle which incorrectly identifies the product and also has incorrect deployment depth marker | 19 units | 2008-02-05 |
| 2005-09-21 | Not classified | Other | Devices for which sterility may be compromised as evidenced by a loss of package integrity. | 2006-01-03 | |
| 2003-10-06 | Not classified | Other | The product displays inaccurate temperature readings, patient skin burns can occur before getting to higher temperature reading. | 137 + 225 units (lot Y082003) | 2004-05-05 |
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.