Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008383115

FEI Number

3008383115

Entity Name

Sinolinks Medical Innovation, Inc.

City/State/Country

ChangZhou Jiangsu, CN

Establishment Address

NO.10 Ziwei Road, Zhonglou Zone, ChangZhou Jiangsu 213032, CN

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

Sinolinks Medical Innovation, Inc. (Owner Number: 10032341)

Owner / Operator Contact Address

NO.10 Ziwei Road, Zhonglou Zone, ChangZhou, CN-JS 213032, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Disposable Trocars Disposable Skin Staple removers Disposable Circular Stapler Disposable Linear Staplers and Reloads Disposable Linear Cutter Staplers and Reloads Disposable Endoscopic Linear Cutter Staplers and Reloads Disposable Curved Cutter Stapler Disposable Hemorrhoidal Stapler Disposable Skin Stapler

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2025-07-15
KDC	Instrument, Surgical, Disposable	General, Plastic Surgery	Class 1	878.4800	2024-07-03
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2015-10-08
QQS	Stapler, Skin	General Hospital	Class 1	878.4740	2024-05-26

Official Correspondent

Juan Zhao

US Agent Details

Wen Xu Email: infor@believe-med.com Phone: (443) 8968583

Related Public Records

Same Entity

Sinolinks Medical Innovation, Inc.

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
K914997	Conmedcorp	ASP-IRRATOR	1992-01-07
K153773	Olympus Medical Systems Corp.	Disposal Lens Cleaning Sheath	2016-11-22
K940141	Micro-Medical Devices, Inc.	LAPARAOSCOPES ELECTRONIC WITH STERILE SHEATH	1994-05-19
K933812	Advanced Surgical, Inc.	ADVANCED SURGICAL, INC. CANNULA CLEANING DEVICE AND ACCESSORIES	1993-12-13
K254228	Karl Storz SE & CO. KG	KARL STORZ Trocars with Valve Seals	2026-05-11

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Banding Kit, REF: K0398 Contains: (2) C0Q04, 5x100mm Threaded Kii Access System (1) C0604, 15x100mm Non-Threaded Separator System w/Universal Seal, for laparoscopic procedures.
Z-0028-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Banding Kit, REF: K0406 Contains: (1) C0658, 11x100mm Threaded Shielded Trocar w/Universal Seal (1) C0522, 5x100mm Threaded Premium Flat Blade (1) C2202, 150mm Insufflation needle (1) C0605, 15x100mm Threaded Separator Access System (1) CB030, 5mm x 35cm Direct Drive Disposable Scissors (2) C4120, 5mm x 38cm Direct Drive Grasper Reposable Cartridge, for laparoscopic procedures.
Z-0029-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Roux-EN-Y Kit, REF: K2129 Contains: (1) C0Q04, 5x100mm Threaded Kii Access System (1) C0130, 12x100mm Optical Separator System, Non-handled (2) C0Q10, 5x100mm Threaded Kii Cannula and Seal (1) C0605, 15mmx100mm Threaded Cannula System, for laparoscopic procedures.
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.

Similar Registrations

Registration Number	Establishment Name	Location
3016804805	CLEARCAM	Austin, TX, US
3011936016	Sony Olympus Medical Solutions Inc.	Hachioji-shi Tokyo, JP
3015335150	VERNACARE LTD.	Chorley Lancashire, GB
1221072	VASCULAR TECHNOLOGY INCORPORATED	NASHUA, NH, US
3021744308	Lazurite Inc.	Cleveland, OH, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008383115. Last updated year: 2026. Please use registration number 3008383115 when referencing this establishment in official correspondence.