Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014264910

FEI Number

3014264910

Entity Name

EZISURG MEDICAL CO., LTD.

City/State/Country

Shanghai, CN

Establishment Address

No. 399, Miaoqiao Rd., Pudong New District,, Shanghai 201315, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Ezisurg Medical Co., Ltd. (Owner Number: 10056707)

Owner / Operator Contact Address

No. 399, Miaoqiao Rd., Pudong New District, Shanghai, CN-SH 201315, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K210909

PMA Number

N/A

All Registered Proprietary Names

easyEndo Pro Loading Unit (L30W, L30B, L45W, L45B, L45C, L45G, L60W, L60B, L60C, L60G) easyEndo Universal Linear Cutting Stapler (U12S, U12M, U12L) easyEndo Linear Cutting Stapler for Single Use (F12S, F12M, F12L) easyEndo Loading Units for Single Use (FDU45W, FDU45B, FDU45G, FDU60B, FDU60G) easyEndo Flex Loading Unit (R30W, R30B, R45W, R45B, R45C, R45G, R60W, R60B, R60C, R60G) easyEndoTM Universal Linear Cutting Stapler and Loading Units for Single Use easyEndoTM Linear Cutting Stapler and Loading Units for Single Use easyLC Linear Cutter Staplers (LCE60, LCE80, LCE100, LCE60B, LCE60G, LCE80G, LCE100B) easyCS Circular Stapler for Single Use (CS2135, CS2148, CS2535, CS2548, CS2935, CS2948, CS3148, CS3348) easyLC Loading Unit (LCC60W, LCC60B, LCC60G, LCC80B, LCC80G, LCC100B, LCC100G) easyEndo Lite Linear Cutting Stapler for Single Use (U12S45, U12S60, U12M45, U12M60, U12L45, U12L60) easyEndo Lite Loading Units for Single Use (N45M, N45W, N45B, N45C, N45G, N60M, N60W, N60B, N60C, N60G)

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	2018-01-08
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2018-01-08
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2020-11-08
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2021-07-14
GAG	Stapler, Surgical	General Hospital	Class 2	878.4740	2021-07-14

Official Correspondent

No official correspondent registered.

US Agent Details

Yong Sun Business: Emergo Global Representation LLC Email: USAgent@ul.com Phone: (512) 3279997

Related Public Records

Same Entity

Ezisurg Medical Co., Ltd.

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

View Entity Profile →

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 3014264910. Last updated year: 2026. Please use registration number 3014264910 when referencing this establishment in official correspondence.