Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007222388

FEI Number

3007222388

Entity Name

TOUCHSTONE INTERNATIONAL MEDICAL SCIENCE CO., LTD.

City/State/Country

Suzhou Jiangsu, CN

Establishment Address

278 Dongping Street, Suzhou Industrial Park,, Suzhou Jiangsu 215123, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Touchstone International Medical Science Co., Ltd. (Owner Number: 10027069)

Owner / Operator Contact Address

278 Dongping Street, Suzhou Industrial Park,, Suzhou, CN-JS 215123, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K141097

PMA Number

N/A

All Registered Proprietary Names

Circumcision Stapler for Single Use Auto Purse String Clamp for Single Use TST Series Tissue-Selecting Therapy Stapler PPH Series PPH Stapler and Purse Sets for Single Use CSC Series Intraluminal Stapler for Single Use CST Series Intraluminal Stapler for Single Use

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GDT	Staple, Removable (Skin)	General, Plastic Surgery	Class 1	878.4760	2019-12-08
FHM	Apparatus, Suturing, Stomach And Intestinal	General, Plastic Surgery	Class 1	878.4800	2008-09-24
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2016-07-08

Official Correspondent

Mengnan Hu

US Agent Details

Hui Chen Email: yulin@touchstone.hk Phone: (301) 3301047

Related Public Records

Same Entity

Touchstone International Medical Science 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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007222388. Last updated year: 2026. Please use registration number 3007222388 when referencing this establishment in official correspondence.