Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010326740

FEI Number

3010326740

Entity Name

Medtronic (Shanghai) Medical Technology Co., Ltd.

City/State/Country

Min Hang District Shanghai, CN

Establishment Address

Rooms 501, 502, 601, 602, No.3 Building, No.2388, Chen Hang Road, Min Hang District Shanghai 201114, CN

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Covidien llc (Owner Number: 1282497)

Owner / Operator Contact Address

15 HAMPSHIRE STREET, --, Mansfield, MA 02048, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K231934

PMA Number

N/A

All Registered Proprietary Names

EEA Circular Stapler with Tri-Staple Technology LigaSure Curved Jaw Open Reusable Clamp LigaSure Curved Jaw Open Sealer/Divider Electrode EEA Circular Stapler with Tri-Staple Technology EEA Circular Stapler with Tri-Staple Technology Puritan Bennett Cuff Pressure Manager GIA Stapler with Tri-Staple Technology EEA Circular Stapler with Tri-Staple Transoral Circular Stapler Anvil Technology and OrVil GIA Stapler with Tri-Staple Technology GIA Stapler with Tri-Staple Technology

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2020-01-31
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2016-09-08
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2022-12-02
GAG	Stapler, Surgical	General Hospital	Class 2	878.4740	2022-12-02
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2023-05-23
GAG	Stapler, Surgical	General Hospital	Class 2	878.4740	2023-05-23
BSK	Cuff, Tracheal Tube, Inflatable	Anesthesiology	Class 2	868.5750	2021-01-15
GAG	Stapler, Surgical	General Hospital	Class 2	878.4740	2023-03-29
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2023-03-29
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2024-12-09
GAG	Stapler, Surgical	General Hospital	Class 2	878.4740	2024-12-09
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2020-04-06
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2023-11-01
GAG	Stapler, Surgical	General Hospital	Class 2	878.4740	2023-11-01

Official Correspondent

Marsha Seetaram

US Agent Details

Wing Ng Email: wing.k.ng@medtronic.com Phone: (508) 2616596

Related Public Records

Same Entity

Covidien llc

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
8020889	Mallinckrodt Medical	ATHLONE Westmeath, IE
3006451981	Covidien Medical Products (Shanghai) Manufacturing LLC	Shanghai, CN
8044004	ORIDION MEDICAL 1987 LTD.	JERUSALEM, IL
1282497	Covidien LLC	MANSFIELD, MA, US
9681384	Covidien	Ciudad Juarez Chihuahua, MX

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K131563	Opus Ksd, Inc.	SUBQ IT! BIOABSORBABLE SKIN CLOSURE SYSTEM	2014-04-09
K131705	Covidien, Formerly US Surgical A Divison of Tyco H	ENDO GIA RADIAL RELOAD WITH TRI-STAPLE TECHNOLOGY	2013-07-01
K103263	Covidien, Formerly US Surgical A Divison of Tyco H	ENDO GIA SINGLEUSE DUET TRS RELOAD WITH TRI0STAPLE TECHNOLOGY	2010-11-22
K130717	Covidien, Formerly US Surgical A Divison of Tyco H	ENDO GIA RELOAD	2013-04-18
K221006	Covidien	GIA Stapler with Tri-Staple Technology	2022-04-29

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2021	N/A	2	Endo GIA Auto Suture Gray Universal Articulating Loading Unit 30 mm - 2.0 mm, Item Code 030450 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.
Z-0002-2021	N/A	2	Endo GIA Auto Suture Universal Articulating Loading Unit 30 mm - 2.5 mm, Item Code 030451 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.
Z-0003-2021	N/A	2	Endo GIA Auto Suture Universal Articulating Loading Unit 30 mm - 3.5 mm, Item Code 030452 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.
Z-0004-2021	N/A	2	Endo GIA Auto Suture Universal Articulating Loading Unit 45 mm - 2.0 mm, Item Code 030453 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.
Z-0005-2021	N/A	2	Endo GIA Auto Suture Universal Loading Unit 45 mm - 2.5mm, Item Code 030454 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.

Similar Registrations

Registration Number	Establishment Name	Location
1047423	Atalys	Asheboro, NC, US
3013942591	INTUITIVE SURGICAL, INC.	Sunnyvale, CA, US
1219930	Covidien	North Haven, CT, US
3015612252	INTUITIVE SURGICAL, INC.	Santa Clara, CA, US
3013283620	Intuitive Surgical G.K.	Tokyo, JP

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010326740. Last updated year: 2026. Please use registration number 3010326740 when referencing this establishment in official correspondence.