Zinnanti Surgical
Smoke-Evac Fusion Electrosurgical Pencil II-with Extended Cap & 2" Teflon Blade
65manufacturers in China registered for this device type
40catalogue numbers in this listing
1recall
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 | Zinnanti Surgical Design Group 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) | K935947 |
| Record published | 2024-01-25 |
| Record revised | 2023-04-04 (version 2) |
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, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 14-1002PA | In distribution | |
| 14-1508 | In distribution | |
| ZSE25 | In distribution | |
| 14-1045T | In distribution | |
| 14-2008 | In distribution | |
| 14-1023DS | In distribution | |
| 14-1023DB | In distribution | |
| Z-1300 | In distribution | |
| 14-0210 | In distribution | |
| 14-2012 | In distribution | |
| 14-1004L | In distribution | |
| 14-1016 | In distribution | |
| 14-1008S | In distribution | |
| 14-1002P | In distribution | |
| 14-0505 | In distribution | |
| 14-1046 | In distribution | |
| 14-1066P | In distribution | |
| 14-1004S | In distribution | |
| 13-1023DB | In distribution | |
| 14-0005 | In distribution | |
| 14-1004P | In distribution | |
| 14-2510 | In distribution | |
| 14-1015 | In distribution | |
| 14-0120 | In distribution | |
| 14-0003 | In distribution | |
| 14-1056 | In distribution | |
| 14-2010 | In distribution | |
| 14-1010S | In distribution | |
| 14-0115 | In distribution | |
| 14-1010 | In distribution | |
| 14-1036 | In distribution | |
| 13-1023DS | In distribution | |
| ZS25 | In distribution | |
| 14-2015 | In distribution | |
| 14-1006P | In distribution | |
| 14-2001 | In distribution | |
| 14-1515 | In distribution | |
| 14-2020 | In distribution | |
| 14-1512 | In distribution | |
| 14-0110 | 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
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2007-07-12 | Not classified | Other | Bubble Leak Test Failure of sterility barrier, therefore sterility of the device may be compromised | 8, 860 units | 2008-03-07 |
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.