Snowden-Pencer
Snowden-Pencer MIS DIAMOND-LINE SCISSORS SWITCH-BLADE METZENBAUM SHAFT 5MM, 24CM, INSULATED HANDLE, ESU
65manufacturers in China registered for this device type
13catalogue numbers in this listing
2510(k) clearances naming this product code
40recalls 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 | Carefusion 2200, 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, Complaint-file establishment, Manufacturer |
| Record published | 2016-09-24 |
| Record revised | 2022-03-08 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Distribution end date | 2021-09-09 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SP90-4011 | Withdrawn | |
| SP90-4205 | Withdrawn | |
| SP90-4213 | Withdrawn | |
| SP90-4204 | Withdrawn | |
| SP90-1150 | Withdrawn | |
| SP90-4200 | Withdrawn | |
| 88-9400 | Withdrawn | |
| SP90-4211 | Withdrawn | |
| SP90-4202 | Withdrawn | |
| SP90-4206 | Withdrawn | |
| SP90-4210 | Withdrawn | |
| SP90-5004 | Withdrawn | |
| SP90-4212 | Withdrawn |
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 |
|---|---|
| K163615 | 2017-05-04 |
| K113407 | 2012-09-07 |
Recalls
40 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 |
|---|---|---|---|---|
| 2022-11-02 | Class II | Under Investigation by firm | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer’s IFU. This missing content is related to the interface with the device power supply, as well as cleaning | 132 units |
| 2022-11-02 | Class II | Under Investigation by firm | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer’s IFU. This missing content is related to the interface with the device power supply, as well as cleaning | 17 units |
| 2022-11-02 | Class II | Under Investigation by firm | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer’s IFU. This missing content is related to the interface with the device power supply, as well as cleaning | 236 units |
| 2022-11-02 | Class II | Under Investigation by firm | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer’s IFU. This missing content is related to the interface with the device power supply, as well as cleaning | 19 units |
| 2022-11-02 | Class II | Under Investigation by firm | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer’s IFU. This missing content is related to the interface with the device power supply, as well as cleaning | 84 units |
| 2022-11-02 | Class II | Under Investigation by firm | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer’s IFU. This missing content is related to the interface with the device power supply, as well as cleaning | 1810 units |
| 2022-11-02 | Class II | Under Investigation by firm | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer’s IFU. This missing content is related to the interface with the device power supply, as well as cleaning | 142 units |
| 2022-11-02 | Class II | Under Investigation by firm | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer’s IFU. This missing content is related to the interface with the device power supply, as well as cleaning | 41 units |
| 2022-11-02 | Class II | Under Investigation by firm | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer’s IFU. This missing content is related to the interface with the device power supply, as well as cleaning | 25 units |
| 2022-11-02 | Class II | Under Investigation by firm | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer’s IFU. This missing content is related to the interface with the device power supply, as well as cleaning | 1063 units |
| 2022-11-02 | Class II | Under Investigation by firm | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer’s IFU. This missing content is related to the interface with the device power supply, as well as cleaning | 9 units |
| 2022-11-02 | Class II | Under Investigation by firm | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer’s IFU. This missing content is related to the interface with the device power supply, as well as cleaning | 2 unist |
| 2022-11-02 | Class II | Under Investigation by firm | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer’s IFU. This missing content is related to the interface with the device power supply, as well as cleaning | 347 units |
| 2022-11-02 | Class II | Under Investigation by firm | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer’s IFU. This missing content is related to the interface with the device power supply, as well as cleaning | 21 units |
| 2022-11-02 | Class II | Under Investigation by firm | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer’s IFU. This missing content is related to the interface with the device power supply, as well as cleaning | 45 units |
| 2022-11-02 | Class II | Under Investigation by firm | XXX | 4 units |
| 2022-11-02 | Class II | Under Investigation by firm | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer’s IFU. This missing content is related to the interface with the device power supply, as well as cleaning | 28 units |
| 2022-11-02 | Class II | Under Investigation by firm | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer’s IFU. This missing content is related to the interface with the device power supply, as well as cleaning | 119 units |
| 2022-11-02 | Class II | Under Investigation by firm | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer’s IFU. This missing content is related to the interface with the device power supply, as well as cleaning | 100 units |
| 2022-11-02 | Class II | Under Investigation by firm | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer’s IFU. This missing content is related to the interface with the device power supply, as well as cleaning | 15 units |
| 2022-11-02 | Class II | Under Investigation by firm | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer’s IFU. This missing content is related to the interface with the device power supply, as well as cleaning | 79 units |
| 2022-11-02 | Class II | Under Investigation by firm | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer’s IFU. This missing content is related to the interface with the device power supply, as well as cleaning | 27 units |
| 2022-11-02 | Class II | Under Investigation by firm | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer’s IFU. This missing content is related to the interface with the device power supply, as well as cleaning | 1369 units |
| 2022-11-02 | Class II | Under Investigation by firm | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer’s IFU. This missing content is related to the interface with the device power supply, as well as cleaning | 40 units |
| 2022-11-02 | Class II | Under Investigation by firm | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer’s IFU. This missing content is related to the interface with the device power supply, as well as cleaning | 46 units |
| 2022-11-02 | Class II | Under Investigation by firm | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer’s IFU. This missing content is related to the interface with the device power supply, as well as cleaning | 52 units |
| 2022-11-02 | Class II | Under Investigation by firm | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer’s IFU. This missing content is related to the interface with the device power supply, as well as cleaning | 30 units |
| 2022-11-02 | Class II | Under Investigation by firm | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer’s IFU. This missing content is related to the interface with the device power supply, as well as cleaning | 128 units |
| 2022-11-02 | Class II | Under Investigation by firm | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer’s IFU. This missing content is related to the interface with the device power supply, as well as cleaning | 24 units |
| 2022-11-02 | Class II | Under Investigation by firm | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer’s IFU. This missing content is related to the interface with the device power supply, as well as cleaning | 35 units |
| 2022-11-02 | Class II | Under Investigation by firm | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer’s IFU. This missing content is related to the interface with the device power supply, as well as cleaning | 32 units |
| 2022-11-02 | Class II | Under Investigation by firm | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer’s IFU. This missing content is related to the interface with the device power supply, as well as cleaning | 239 units |
| 2022-11-02 | Class II | Under Investigation by firm | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer’s IFU. This missing content is related to the interface with the device power supply, as well as cleaning | 11 units |
| 2022-11-02 | Class II | Under Investigation by firm | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer’s IFU. This missing content is related to the interface with the device power supply, as well as cleaning | 147 units |
| 2022-11-02 | Class II | Under Investigation by firm | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer’s IFU. This missing content is related to the interface with the device power supply, as well as cleaning | 18 units |
| 2022-11-02 | Class II | Under Investigation by firm | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer’s IFU. This missing content is related to the interface with the device power supply, as well as cleaning | 57 units |
| 2022-11-02 | Class II | Under Investigation by firm | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer’s IFU. This missing content is related to the interface with the device power supply, as well as cleaning | 218 units |
| 2022-11-02 | Class II | Under Investigation by firm | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer’s IFU. This missing content is related to the interface with the device power supply, as well as cleaning | 25 units |
| 2022-11-02 | Class II | Under Investigation by firm | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer’s IFU. This missing content is related to the interface with the device power supply, as well as cleaning | 5 units |
| 2022-11-02 | Class II | Under Investigation by firm | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer’s IFU. This missing content is related to the interface with the device power supply, as well as cleaning | 418 units |
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.