Wilson Instruments (SHA) Co., Ltd.
Registered establishment in Shanghai, China. 10 device types, 1 clearance.
Wilson Instruments (SHA) Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Accessories, Catheter, Endoscopic Bite Block and 8 other device types. Its earliest product listing with the FDA dates from 2009.
Registration
| Registered name | WILSON INSTRUMENTS (SHA) CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3008048800 |
| FEI number | 3008048800 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 上海威尔逊光电仪器有限公司 |
|---|---|
| Source | Zhihuiya company database |
Location
| City | Shanghai |
|---|---|
| Province | Shanghai |
| Address | Unit 1, Building 12 & Building 7, No.1680 Shengli Road, Qingpu District |
| Postal code | 201712 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Accessories, Catheter | Class 1 | Disposable Spray Catheters | 2010 | 33 |
| Accessories, Cleaning Brushes, For Endoscope | Class 1 | Disposable Cleaning Brushes, Reusable Cleaning Brushes | 2009 | 43 |
| Bottle, Collection, Vacuum | Class 2 | Disposable Polyp Traps | 2017 | 88 |
| Dislodger, Stone, Basket, Ureteral, Metal | Class 2 | Disposable Stone Retrieval Baskets, Disposable Retrieval Baskets | 2015 | 21 |
| Endoscope Channel Accessory | Class 2 | Disposable Endoscope Valves Set A, Disposable Endoscope Valves Set, Disposable Endoscope Valves Set, Disposable Endoscope Valves Set B | 2015 | 21 |
| Endoscopic Bite Block | Class 1 | Disposable Bite Blocks | 2009 | 44 |
| Endoscopic Injection Needle, Gastroenterology-Urology | Class 2 | Disposable Injection Needle | 2015 | 23 |
| Forceps, Biopsy, Non-Electric | Class 1 | Reusable Biopsy Forceps, Disposable Biopsy Forceps | 2009 | 44 |
| Forceps, Wire Holding | Class 1 | Reusable Grasping Forceps | 2011 | 8 |
| Snare, Non-Electrical | Class 1 | Disposable Cold Snares | 2009 | 19 |
Clearances
1 clearance names Wilson Instruments (SHA) Co., Ltd. as applicant. 2 are held by another company and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K200769 | 2021-01-06 | ODC | Traditional | This company |
| K151714 | 2015-12-03 | ODC | Traditional | Wilson Instruments (Shanghai) Company Limited |
| K142144 | 2015-01-15 | FBK | Traditional | Wilson Instruments (Shanghai) Company Limited |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 1995 |
|---|---|
| Main products | Biopsy Devices, Retrieval Instruments, EMR/ESD Equipment, Hemostasis and Closure Tools, ERCP Accessories |
| Certifications | Internet Drug Information Service License, ICP Filing |
Nearby Manufacturers
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.
The manufacturer named here can complete this record.