Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008843439

FEI Number

3008843439

Entity Name

HANGZHOU KANGJI MEDICAL INSTRUMENT CO., LTD.

City/State/Country

HANGZHOU Zhejiang, CN

Establishment Address

No. 1668 Chunjiang East Rd, ECONOMIC DEVELOPMENT ZONE TONGLU, HANGZHOU Zhejiang 311501, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Hangzhou Kangji Medical Instrument Co., Ltd. (Owner Number: 10033746)

Owner / Operator Contact Address

No.1668 Chunjiang East Road, Economic Development Zone, Tonglu, Hangzhou, CN-ZJ 311501, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Trocar and Cannula UROLOGY BIOPSY Reuseble sterilization case Tray for Surgical Instruments DANNIK Laparoscopic Suction Irrigation System Veress Needle Aspir Needle Disposable Trocars Needle Holder Instrument for Cutting Retractor Specimen Bag Specimen Retrieval Bag Trocar and Cannula Dannik Titanium Ligation Clip Closure Forceps VAT Instruments Palpation Probe Suction& Irrigation Guiding Bar Hypodermic Syringe Biopsy Forceps Instruments for E.N.T. Mamual Surgical Clip Applier surgical forceps AEON Retrieval Bag DANNIK Disposable Monopolar Laparoscopic Instrument Grasper Biopsy Forceps

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GEA	Cannula, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2012-02-17
FCL	Forceps, Biopsy, Non-Electric	Gastroenterology, Urology	Class 1	876.1075	2014-08-07
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2013-01-16
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2020-02-23
GDM	Needle, Aspiration And Injection, Reusable	General, Plastic Surgery	Class 1	878.4800	2012-02-17
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2024-04-25
FHQ	Holder, Needle, Gastroenterologic	Gastroenterology, Urology	Class 1	876.4730	2012-02-17
HTZ	Instrument, Cutting, Orthopedic	General, Plastic Surgery	Class 1	878.4800	2013-01-16
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2012-02-17
FMH	Container, Specimen, Sterile	Pathology	Class 1	864.3250	2012-02-17
FBM	Cannula And Trocar, Suprapubic, Non-Disposable	Gastroenterology, Urology	Class 1	876.5090	2012-02-17
FZP	Clip, Implantable	General, Plastic Surgery	Class 2	878.4300	2020-02-23
NNQ	Forceps, Wire Closure, Ent, Non-Sterile	Ear, Nose, Throat	Class 1	874.3540	2013-01-16
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2024-11-20
HFB	Forceps, Biopsy, Gynecological	Obstetrics/Gynecology	Class 1	884.4530	2012-02-16
LRC	Instrument, Ent Manual Surgical	Ear, Nose, Throat	Class 1	874.4420	2013-01-16
HBT	Applier, Hemostatic Clip	General, Plastic Surgery	Class 1	878.4800	2012-02-16
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2014-08-07
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2018-05-22
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2024-04-25
GDI	Dissector, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2012-02-16

Official Correspondent

Cheng Da

US Agent Details

James Wang Business: LLINS TECHNOLOGY INC Email: fda-rep@llins-tech.com Phone: (720) 2171916

Related Public Records

Same Entity

Hangzhou Kangji Medical Instrument 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
K863293	Lifestream Int'L, Inc.	DISPOSABLE SUCTION CANNULA NO. 902008-000	1986-09-09
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

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2016	Zimmer, Inc.	1	Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.
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-0031-2014	Aesculap, Inc.	1	UNITRAC Pneumatic Retraction Arm. A support arm used to hold surgical instruments during surgical procedures.

Similar Registrations

Registration Number	Establishment Name	Location
3023138850	AQ THERAPEUTICS, INC.	Irvine, CA, US
1526439	DEPUY SPINE, INC.	RAYNHAM, MA, US
1058584	Sterigenics US LLC	Charlotte, NC, US
1221763	ARCH Medical Solutions - Seabrook	SEABROOK, NH, US
8043496	REDA INSTRUMENTE GMBH	TUTTLINGEN Baden-Wurttemberg, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008843439. Last updated year: 2026. Please use registration number 3008843439 when referencing this establishment in official correspondence.