Medtronic (Shanghai) Medical Technology Co., Ltd.
Registered establishment in Min Hang District, Shanghai, China. 4 device types.
Medtronic (Shanghai) Medical Technology Co., Ltd. is a specification developer holding a current FDA establishment registration. The registration covers Stapler, Surgical, Staple, Implantable and 2 other device types. Its earliest product listing with the FDA dates from 2016.
Registration
| Status | Registered |
|---|---|
| Registration expires | 2026 |
| Registration number | 3010326740 |
| FEI number | 3010326740 |
| Establishment type | Specification developer, Manufacturer |
Location
| City | Min Hang District |
|---|---|
| Province | Shanghai |
| Address | Rooms 501, 502, 601, 602, No.3 Building |
| Postal code | 201114 |
| Country | China |
Group
Medtronic (Shanghai) Medical Technology Co., Ltd. is one of 2 plants registered under Covidien llc.
| Plant | City | Device types |
|---|---|---|
| Covidien Medical Products (Shanghai) Manufacturing LLC | Shanghai | 8 |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Cuff, Tracheal Tube, Inflatable | Class 2 | Puritan Bennett Cuff Pressure Manager | 2021 | 6 |
| Electrosurgical, Cutting & Coagulation & Accessories | Class 2 | LigaSure Curved Jaw Open Sealer/Divider Electrode, LigaSure Curved Jaw Open Reusable Clamp | 2016 | 65 |
| Staple, Implantable | Class 2 | GIA™ Stapler with Tri-Staple™ Technology, EEA™ Circular Stapler with Tri-Staple™ Technology, Circular Stapler with Tri-Staple™, Transoral Circular Stapler Anvil, Technology and OrVil™, EEA™ and 2 more | 2018 | 16 |
| Stapler, Surgical | Class 2 | GIA™ Stapler with Tri-Staple™ Technology, Circular Stapler with Tri-Staple™, Transoral Circular Stapler Anvil, Technology and OrVil™, EEA™, EEA Circular Stapler with Tri-Staple Technology and 1 more | 2018 | 16 |
Clearances
No clearance names Medtronic (Shanghai) Medical Technology Co., Ltd. as applicant. 12 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 |
|---|---|---|---|---|
| K231934 | 2023-10-27 | GAG | Traditional | Covidien |
| K232126 | 2023-08-16 | GAG | Special | Covidien |
| K221771 | 2022-11-30 | GDW | Traditional | Covidien |
| K221006 | 2022-04-29 | GDW | Special | Covidien |
| K221005 | 2022-04-29 | GDW | Special | Covidien |
| K202507 | 2021-01-21 | GDW | Traditional | Covidien |
| K202874 | 2021-01-09 | BSK | Traditional | Covidien |
| K202701 | 2020-12-07 | GDW | Special | Covidien |
| K192720 | 2020-03-13 | GDW | Traditional | Covidien |
| K192330 | 2020-01-23 | GDW | Traditional | Covidien |
| K172361 | 2018-02-16 | GDW | Traditional | Covidien |
| K160331 | 2016-08-12 | GEI | Traditional | Covidien |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 1995 |
|---|---|
| Main products | medical devices, electrophysiology devices |
| Export markets | Global |
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.