Data / Medical devices / China / Medtronic (Shanghai) Medical Technology Co., Ltd.
Medtronic (Shanghai) Medical Technology Co., Ltd.: FDA-registered device maker in Min Hang District Shanghai, China, 12 510(k) clearances
Medtronic (Shanghai) Medical Technology Co., Ltd. is registered with the FDA (registration 3010326740) in Min Hang District Shanghai, China. It lists 4 device types. The FDA files 12 510(k) clearances under its listings, the newest dated October 27, 2023. Registered through 2027. FDA data exported November 3, 2026.
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- FDA registration number
- 3010326740
- Address
- Rooms 501, 502, 601, 602, No.3 Building No.2388, Chen Hang Road, Min Hang District Shanghai, China, 201114
- Owner or operator
- Covidien llc (1282497)
- Roles
- Specification developer
- First device listed
- September 8, 2016
- Registered through
- 2027
- Brand names listed
- Circular Stapler with Tri-Staple, EEA Circular Stapler with Tri-Staple Technology, EEA'M Circular Stapler with Tri-Staple" Technology, EEA, EEA Circular Stapler with Tri-Staple Technology, GIATM Stapler with Tri-StapleTM Technology, GIA Stapler with Tri-Staple Technology, LigaSure Curved Jaw Open Reusable Clamp and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cuff, Tracheal Tube, Inflatable | BSK | 2 | Specification developer | accessdata.fda.gov |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 2 | Specification developer | accessdata.fda.gov |
| Staple, Implantable | GDW | 2 | Specification developer | accessdata.fda.gov |
| Stapler, Surgical | GAG | 2 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 27, 2023 | K231934 | GIA Stapler with Tri-Staple Technology | GAG | Substantially Equivalent | Covidien | accessdata.fda.gov |
| August 16, 2023 | K232126 | EEACircular Stapler with Tri-Staple Technology and OrVil Transoral Circular Stapler Anvil | GAG | Substantially Equivalent | Covidien | accessdata.fda.gov |
| November 30, 2022 | K221771 | EEA Circular Stapler with Tri-Staple Technology | GDW | Substantially Equivalent | Covidien | accessdata.fda.gov |
| April 29, 2022 | K221006 | GIA Stapler with Tri-Staple Technology | GDW | Substantially Equivalent | Covidien | accessdata.fda.gov |
| April 29, 2022 | K221005 | EEA Circular Stapler with Tri-Staple Technology | GDW | Substantially Equivalent | Covidien | accessdata.fda.gov |
| January 21, 2021 | K202507 | EEA Circular Stapler with Tri-Staple Technology | GDW | Substantially Equivalent | Covidien | accessdata.fda.gov |
| January 9, 2021 | K202874 | Puritan Bennett Cuff Pressure Manager | BSK | Substantially Equivalent | Covidien, LLC | accessdata.fda.gov |
| December 7, 2020 | K202701 | GIA Stapler with Tri-Staple Technology | GDW | Substantially Equivalent | Covidien | accessdata.fda.gov |
| March 13, 2020 | K192720 | GIA Stapler with Tri-Staple Technology | GDW | Substantially Equivalent | Covidien | accessdata.fda.gov |
| January 23, 2020 | K192330 | EEA Circular Stapler with Tri-Staple Technology | GDW | Substantially Equivalent | Covidien | accessdata.fda.gov |
| February 16, 2018 | K172361 | EEA Circular Stapler with Tri-Staple Technology | GDW | Substantially Equivalent | Covidien | accessdata.fda.gov |
| August 12, 2016 | K160331 | LigaSure Curved Jaw, Open Sealer/Divider Electrode, LigaSure Curved Jaw Open Reusable Clamp | GEI | Substantially Equivalent | Covidien | accessdata.fda.gov |
Compare with other makers
- All makers of Staple, Implantable
- All makers of Stapler, Surgical
- All makers of Electrosurgical, Cutting & Coagulation & Accessories
- All makers of Cuff, Tracheal Tube, Inflatable
Updated October 27, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.