Insert, Maryland Dissector, Aggressive
Catalogue number ES0549, listed by Encision, Inc., United States, under Electrosurgical, Cutting & Coagulation & Accessories. 65 manufacturers in China are registered for this product code.
65manufacturers in China registered for this device type
1catalogue number
10510(k) clearances naming this product code
26recalls 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 | Encision, 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 |
| 510(k) | K191612 |
| Record published | 2016-08-31 |
| Record revised | 2020-03-25 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ES0549 | 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 |
|---|---|
| K201018 | 2020-07-15 |
| K191612 | 2020-03-20 |
| K140006 | 2014-06-16 |
| K131949 | 2013-08-26 |
| K122383 | 2013-01-10 |
| K122580 | 2012-11-09 |
| K093622 | 2010-08-20 |
| K100711 | 2010-06-09 |
| K091074 | 2009-08-17 |
| K072789 | 2007-10-19 |
Recalls Naming This Product
8 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Encision, Inc. | 510(k) number | 2011-04-07 | Not classified | Package design/selection | Sterility may be compromised due to holes in packaging. | 574 Ten-Count Boxes, 24 Kits | 2011-08-09 |
| Encision, Inc. | 510(k) number | 2011-04-07 | Not classified | Package design/selection | Sterility may be compromised due to holes in packaging. | 952 Ten-Count Boxes | 2011-08-09 |
| Encision, Inc. | 510(k) number | 2011-04-07 | Not classified | Package design/selection | Sterility may be compromised due to holes in packaging. | 129 Ten-Count Boxes | 2011-08-09 |
| Encision, Inc. | 510(k) number | 2011-04-07 | Not classified | Package design/selection | Sterility may be compromised due to holes in packaging. | 233 Ten Count Boxes, 1 Kit | 2011-08-09 |
| Encision, Inc. | 510(k) number | 2011-04-07 | Not classified | Package design/selection | Sterility may be compromised due to holes in packaging. | 44 Ten-Count Boxes | 2011-08-09 |
| Encision, Inc. | 510(k) number | 2011-04-07 | Not classified | Package design/selection | Sterility may be compromised due to holes in packaging. | 95 Ten-Count Boxes | 2011-08-09 |
| Encision, Inc. | 510(k) number | 2004-06-11 | Not classified | Other | Electrosurgical tip may break or come off during use. | 335 units | 2004-11-09 |
| Encision, Inc. | 510(k) number | 2003-01-15 | Not classified | Other | Reports of needle fixed-tip electrodes becoming loose or breaking off. | 58 devices. | 2003-04-14 |
Recalls
1 of these is 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 |
|---|---|---|---|---|---|
| 2012-06-15 | Class II | Device Design | Encision is performing a field correction to their AEM Disposable Electrodes due to two consumer complaints reporting unanticipated alarms from the AEM monitor while using the device. This issue could result delays or complications during | 48 boxes | 2012-08-07 |
| 2011-08-24 | Not classified | Device Design | Electrode tips have been reported breaking off during use or cleaning. | 604 units | 2012-09-04 |
| 2011-08-24 | Not classified | Device Design | Electrode tips have been reported breaking off during use or cleaning. | 212 units | 2012-09-04 |
| 2011-08-24 | Not classified | Device Design | Electrode tips have been reported breaking off during use or cleaning. | 83 units | 2012-09-04 |
| 2011-08-24 | Not classified | Device Design | Electrode tips have been reported breaking off during use or cleaning. | 10 units | 2012-09-04 |
| 2011-08-24 | Not classified | Device Design | Electrode tips have been reported breaking off during use or cleaning. | 169 units | 2012-09-04 |
| 2010-04-05 | Not classified | Nonconforming Material/Component | Electrosurgical electrode tip insulation may crack and break off during use. | 10 units | 2010-05-21 |
| 2010-04-05 | Not classified | Nonconforming Material/Component | Electrosurgical electrode tip insulation may crack and break off during use. | 20 units | 2010-05-21 |
| 2010-04-05 | Not classified | Nonconforming Material/Component | Electrosurgical electrode tip insulation may crack and break off during use. | 240 units | 2010-05-21 |
| 2010-04-05 | Not classified | Nonconforming Material/Component | Electrosurgical electrode tip insulation may crack and break off during use. | 110 units | 2010-05-21 |
| 2010-04-05 | Not classified | Nonconforming Material/Component | Electrosurgical electrode tip insulation may crack and break off during use. | 130 units | 2010-05-21 |
| 2010-04-05 | Not classified | Nonconforming Material/Component | Electrosurgical electrode tip insulation may crack and break off during use. | 330 units | 2010-05-21 |
| 2010-04-05 | Not classified | Nonconforming Material/Component | Electrosurgical electrode tip insulation may crack and break off during use. | 260 units | 2010-05-21 |
| 2010-04-05 | Not classified | Nonconforming Material/Component | Electrosurgical electrode tip insulation may crack and break off during use. | 40 units | 2010-05-21 |
| 2004-07-09 | Not classified | Other | Firm found pinholes in packaging which would compromise sterility. | 73 units | 2004-12-14 |
| 2003-06-23 | Not classified | Other | Use of NC versions of AEM monitor presents burn hazard when used with single pad and capacitively coupled patient return electrodes. | 4 units | 2003-11-06 |
| 2003-06-23 | Not classified | Other | Use of NC versions of AEM monitor presents burn hazard when used with single pad and capacitively coupled patient return electrodes. | 21 units | 2003-11-06 |
| 2003-06-23 | Not classified | Other | Use of NC versions of AEM monitor presents burn hazard when used with single pad and capacitively coupled patient return electrodes. | 2 units | 2003-11-06 |
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.