Endopath
Endopath Electrosurgery Probe Plus II 5mm Curved Dissector Monopolar Electrosurgery Suction and Irrrigation Shafts with Curved Dissector Electrode - Use only with Probe Plus II Handles
65manufacturers in China registered for this device type
15catalogue numbers in this listing
25510(k) clearances naming this product code
6recalls 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 | Ethicon Endo-Surgery, Inc., United States |
|---|---|
| FDA product code | GEI |
| Device type | Electrosurgical, Cutting & Coagulation & Accessories |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4400 |
| Establishment | Specification developer, Manufacturer, Exporter |
| 510(k) | K904993 |
| Record published | 2016-07-15 |
| Record revised | 2026-04-06 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Hydrogen Peroxide, Moist Heat or Steam Sterilization, Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Handling environment humidity 10 to 80 % RH; Storage environment temperature -22 to 60 °C |
| Packaging | Box of 6, case of 12, case of 24, case of 18, case of 36, case of 25 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5DCS | In distribution | |
| EPS02 | In distribution | |
| EBC05 | In distribution | |
| EPS01 | In distribution | |
| EPH02 | In distribution | |
| EPS03 | In distribution | |
| 5DCD | In distribution | |
| EPS04 | In distribution | |
| EBF02 | In distribution | |
| EBF01 | In distribution | |
| EPS06 | In distribution | |
| EPS07 | In distribution | |
| EPH04 | In distribution | |
| EPS05 | In distribution | |
| EBC02 | 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 |
|---|---|
| K230387 | 2023-04-13 |
| K201696 | 2021-01-22 |
| K201066 | 2021-01-22 |
| K200253 | 2020-05-27 |
| K200841 | 2020-05-11 |
| K180403 | 2018-05-23 |
| K180031 | 2018-05-07 |
| K172580 | 2017-11-20 |
| K163548 | 2017-02-14 |
| K160554 | 2016-09-09 |
| K160128 | 2016-04-28 |
| K141122 | 2014-09-15 |
| K131435 | 2013-10-03 |
| K122797 | 2013-01-25 |
| K123141 | 2012-10-25 |
| K101520 | 2010-12-10 |
| K091259 | 2010-01-15 |
| K091824 | 2009-11-27 |
| K091290 | 2009-10-29 |
| K082955 | 2009-01-15 |
| K073046 | 2008-02-25 |
| K002981 | 2001-04-09 |
| K990362 | 1999-09-17 |
| K984240 | 1999-06-22 |
| K961264 | 1996-07-19 |
Recalls
4 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 |
|---|---|---|---|---|---|
| 2019-05-15 | Class II | Under Investigation by firm | Observed reported incidence rate for harm associated with intraoperative bleeding | 1059 boxes | 2020-06-11 |
| 2019-05-15 | Class II | Under Investigation by firm | Observed reported incidence rate for harm associated with intraoperative bleeding | 228 boxes | 2020-06-11 |
| 2019-05-15 | Class II | Under Investigation by firm | Observed reported incidence rate for harm associated with intraoperative bleeding | 308 boxes | 2020-06-11 |
| 2012-11-06 | Class II | Process control | Potential for self activation while the device is in use, which may result in unintended thermal damage. | 58,338 Instruments | 2014-04-11 |
| 2012-01-26 | Not classified | Nonconforming Material/Component | Ethicon Endo-Surgery initiated a voluntary global recall for specific production lots of ENSEAL G2 Curved and Straight Tissue Sealers due to two potential issues that may occur related to the activation button: (i) Continuous Activation: | 72 pieces | 2013-02-15 |
| 2009-03-27 | Not classified | Other | The firm initiated this second subsequent recall because the affected devices can remain closed and clamped on tissue during surgical procedures due to the fact that the mechanism which connects the articulation joint to the device shaft is | 29,403 units | 2013-02-15 |
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.