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Data / Medical devices / China / Hangzhou Kangji Medical Instrument Co., Ltd.

Hangzhou Kangji Medical Instrument Co., Ltd.: FDA-registered device maker in HANGZHOU Zhejiang, China, 3 510(k) clearances

Hangzhou Kangji Medical Instrument Co., Ltd. is registered with the FDA (registration 3008843439) in HANGZHOU Zhejiang, China. It lists 27 device types. The FDA files 3 510(k) clearances under its listings, the newest dated November 20, 2025. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this oneWatch Hangzhou Kangji Medical Instrument Co., Ltd.
FDA registration number
3008843439
Address
No. 1668 Chunjiang East Rd ECONOMIC DEVELOPMENT ZONE TONGLU, HANGZHOU Zhejiang, China, 311501
Owner or operator
Hangzhou Kangji Medical Instrument Co., Ltd. (10033746)
Roles
Contract manufacturer, Manufacturer
First device listed
February 16, 2012
Registered through
2026
Brand names listed
AEON Retrieval Bag, Aspir Needle, Bile Duct Scalpel, Biopsy Forceps, Clip Applier, Clip Remover, Closure Forceps, DANNIK Disposable Monopolar Laparoscopic Instrument and more

Devices it lists

DeviceProduct codeClassRoleSource
Applier, Hemostatic ClipHBT1Manufactureraccessdata.fda.gov
Cannula And Trocar, Suprapubic, Non-DisposableFBM1Manufactureraccessdata.fda.gov
Cannula, Surgical, General & Plastic SurgeryGEA1Manufactureraccessdata.fda.gov
Clamp, UterineHGC1Manufactureraccessdata.fda.gov
Clip, ImplantableFZP2Contract manufacturer, Manufactureraccessdata.fda.gov
Container, Specimen, SterileFMH1Manufactureraccessdata.fda.gov
Dissector, Surgical, General & Plastic SurgeryGDI1Manufactureraccessdata.fda.gov
Electrosurgical, Cutting & Coagulation & AccessoriesGEI2Contract manufactureraccessdata.fda.gov
ForcepsHTD1Manufactureraccessdata.fda.gov
Forceps, Biopsy, GynecologicalHFB1Manufactureraccessdata.fda.gov
Forceps, Biopsy, Non-ElectricFCL1Manufactureraccessdata.fda.gov
Forceps, Wire Closure, Ent, Non-SterileNNQ1Manufactureraccessdata.fda.gov
Holder, Needle, GastroenterologicFHQ1Manufactureraccessdata.fda.gov
Instrument, Clip RemovalHBQ1Manufactureraccessdata.fda.gov
Instrument, Cutting, OrthopedicHTZ1Manufactureraccessdata.fda.gov
Instrument, Ent Manual SurgicalLRC1Manufactureraccessdata.fda.gov
Instrument, Ligature Passing And Knot TyingHCF1Manufactureraccessdata.fda.gov
Instrument, Manual, General Obstetric-GynecologicKOH1Manufactureraccessdata.fda.gov
Instrument, Manual, Surgical, General UseMDM1Manufactureraccessdata.fda.gov
Insufflator, LaparoscopicHIF2Manufactureraccessdata.fda.gov
Knife, SurgicalEMF1Manufactureraccessdata.fda.gov
Laparoscope, General & Plastic SurgeryGCJ2Contract manufacturer, Manufactureraccessdata.fda.gov
Needle, Aspiration And Injection, ReusableGDM1Manufactureraccessdata.fda.gov
Pneumoperitoneum NeedleFHO2Manufactureraccessdata.fda.gov
RetractorGAD1Manufactureraccessdata.fda.gov
Scissors, General, SurgicalLRW1Manufactureraccessdata.fda.gov
Tray, Surgical, InstrumentFSM1Manufactureraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
November 20, 2025K250643Disposable Polymer Ligation ClipsFZPSubstantially EquivalentHangzhou Kangji Medical Instrument Co., Ltd.accessdata.fda.gov
April 9, 2024K233263Disposable TrocarsGCJSubstantially EquivalentHangzhou Kangji Medical Instrument Co., Ltd.accessdata.fda.gov
December 14, 2023K232401Disposable Veress NeedlesHIFSubstantially EquivalentHangzhou Kangji Medical Instrument Co., Ltd.accessdata.fda.gov

Compare with other makers

Updated November 20, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.