Electrosurgical, Cutting & Coagulation & Accessories
Soft Tissue Ablator 90 Electrode w/Integrated Handpiece
65manufacturers in China registered for this device type
5catalogue numbers in this listing
4510(k) clearances naming this product 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 | Stryker Sustainability Solutions, United States |
|---|---|
| FDA product code | GEI |
| Device type | Electrosurgical, Cutting & Coagulation & Accessories |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4400 |
| Establishment | Reprocessor, Specification developer, Manufacturer |
| 510(k) | K012695 |
| Record published | 2022-06-10 |
| Record revised | 2023-12-18 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment humidity 0 to 90 % RH; Storage environment temperature -18 to 60 °C |
| Packaging | Pack of 4, case of 6 |
| Sizes | Length 21 to 23 cm; length 160 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| LF2019 | Length 21.0 cm | In distribution |
| N/A | Degree: 90.0 Degree | In distribution |
| LXMJ23L | Length 23.0 cm | In distribution |
| N/A | Diameter: 3.5 Millimeter | In distribution |
| N/A | Degree: 90.0 Degree | 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 |
|---|---|
| K260636 | 2026-06-18 |
| K230255 | 2023-03-28 |
| K220481 | 2022-05-25 |
| K172856 | 2017-11-16 |
Recalls Naming This Product
5 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 |
|---|---|---|---|---|---|---|---|
| Stryker Sustainability Solutions Lakeland | 510(k) number | 2009-06-01 | Not classified | Process control | On 06/09/2009, Stryker Sustain ability Solutions, formerly Ascent Healthcare Solutions, recalled lots 674201 & 674290 of their Reprocessed Mitek Arthroscopic Wand due to the lots not being tested in accordance with the functional test requi | 48 | 2012-05-07 |
| Stryker Sustainability Solutions Lakeland | 510(k) number | 2008-03-11 | Not classified | Process control | Sterility Compromised — Ascent Healthcare Solutions cannot validate the sterilization process for a variety of Ascent Healthcare Solutions products. | 16 of 16 | 2012-06-29 |
| Stryker Sustainability Solutions Lakeland | 510(k) number | 2008-03-11 | Not classified | Process control | Sterility Compromised — Ascent Healthcare Solutions cannot validate the sterilization process for a variety of Ascent Healthcare Solutions products. | 16 of 16 | 2012-06-29 |
| Stryker Sustainability Solutions Lakeland | 510(k) number | 2008-03-11 | Not classified | Process control | Sterility Compromised — Ascent Healthcare Solutions cannot validate the sterilization process for a variety of Ascent Healthcare Solutions products. | 4 of 4 | 2012-06-29 |
| Stryker Sustainability Solutions Lakeland | 510(k) number | 2008-03-11 | Not classified | Process control | Sterility Compromised — Ascent Healthcare Solutions cannot validate the sterilization process for a variety of Ascent Healthcare Solutions products. | 4 of 4 | 2012-06-29 |
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.