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Data / Medical devices / China / Beijing ZKSK Technology Co., Ltd.

Beijing ZKSK Technology Co., Ltd.: FDA-registered device maker in beijing, China, 6 510(k) clearances

Beijing ZKSK Technology Co., Ltd. is registered with the FDA (registration 3014620201) in beijing, China. It lists 38 device types. The FDA files 6 510(k) clearances under its listings, the newest dated February 6, 2025. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this oneWatch Beijing ZKSK Technology Co., Ltd.
FDA registration number
3014620201
Address
Building 9, 6 & No.6 Yuan Hengye North 7th street, Yongle Economic Development Zone, Tongzhou District, beijing, China, 101105
Owner or operator
Beijing ZKSK Technology Co., Ltd. (10064072)
Roles
Contract manufacturer, Manufacturer
First device listed
March 23, 2020
Registered through
2026
Brand names listed
Absorbent Cotton, Absorbent Cotton Ball, Absorbent Cotton, Absorbent Cotton Ball, Medical Cotton Swabs, CPE Gown, Dental Instrument Forceps, Dental Instrument Kit, Dental Probe, Dental Tweezers, Disposable Biopsy Forceps and more

Devices it lists

DeviceProduct codeClassRoleSource
Applicator, Absorbent Tipped, SterileKXG1Contract manufacturer, Manufactureraccessdata.fda.gov
Bag, IceKYR1Contract manufacturer, Manufactureraccessdata.fda.gov
Bandage, ElasticFQM1Contract manufacturer, Manufactureraccessdata.fda.gov
Cap, SurgicalFYF1Contract manufacturer, Manufactureraccessdata.fda.gov
Clip, ImplantableFZP2Contract manufacturer, Manufactureraccessdata.fda.gov
Cotton, RollEFN1Contract manufacturer, Manufactureraccessdata.fda.gov
Cover, Shoe, Operating-RoomFXP1Contract manufacturer, Manufactureraccessdata.fda.gov
Depressor, Metal Tongue, SurgicalKBL1Contract manufacturer, Manufactureraccessdata.fda.gov
Depressor, Tongue, Non-SurgicalFMA1Contract manufacturer, Manufactureraccessdata.fda.gov
Dilator, CatheterGCC1Contract manufacturer, Manufactureraccessdata.fda.gov
Dress, SurgicalFYE1Contract manufacturer, Manufactureraccessdata.fda.gov
Endoscopic Grasping/Cutting Instrument, Non-Powered, ExemptPTS2Manufactureraccessdata.fda.gov
Endoscopic Guidewire, Gastroenterology-UrologyOCY2Contract manufacturer, Manufactureraccessdata.fda.gov
Endoscopic Injection Needle, Gastroenterology-UrologyFBK2Manufactureraccessdata.fda.gov
Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella EuaQKRNContract manufacturer, Manufactureraccessdata.fda.gov
First Aid Kit With DrugLRRNContract manufacturer, Manufactureraccessdata.fda.gov
Forceps, Biopsy, ElectricKGE2Manufactureraccessdata.fda.gov
Forceps, Biopsy, Non-ElectricFCL1Contract manufacturer, Manufactureraccessdata.fda.gov
Forceps, Dressing, DentalEFL1Contract manufacturer, Manufactureraccessdata.fda.gov
Forceps, Tooth Extractor, SurgicalEMG1Contract manufacturer, Manufactureraccessdata.fda.gov
Hemostatic Metal Clip For The Gi TractPKL2Manufactureraccessdata.fda.gov
Instruments, Dental HandDZN1Contract manufacturer, Manufactureraccessdata.fda.gov
Lavage, JetFQH2Contract manufacturer, Manufactureraccessdata.fda.gov
Ligator, EsophagealMND2Contract manufacturer, Manufactureraccessdata.fda.gov
Ligator, HemorrhoidalFHN2Manufactureraccessdata.fda.gov
Mask, ScavengingKHA1Contract manufacturer, Manufactureraccessdata.fda.gov
Mirror, MouthEAX1Contract manufacturer, Manufactureraccessdata.fda.gov
Mixer, Cement, For Clinical UseJDZ1Manufactureraccessdata.fda.gov
Non-Surgical GownOEA1Contract manufacturer, Manufactureraccessdata.fda.gov
Probe, PeriodonticEIX1Contract manufacturer, Manufactureraccessdata.fda.gov
Respirator, SurgicalMSH2Contract manufacturer, Manufactureraccessdata.fda.gov
Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)HOY1Contract manufacturer, Manufactureraccessdata.fda.gov
Snare, FlexibleFDI2Manufactureraccessdata.fda.gov
Splint, Hand, And ComponentsILH1Contract manufacturer, Manufactureraccessdata.fda.gov
Suit, SurgicalFXO1Manufactureraccessdata.fda.gov
Thermometer, Clinical Color ChangeFQZ1Contract manufacturer, Manufactureraccessdata.fda.gov
Tourniquet, NonpneumaticGAX1Contract manufacturer, Manufactureraccessdata.fda.gov
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)KNS2Manufactureraccessdata.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
February 6, 2025K242192Disposable SphincterotomeKNSSubstantially EquivalentBeijing Zksk Technology Co., Ltd.accessdata.fda.gov
December 14, 2023K231721Disposable Hot Biopsy ForcepsKGESubstantially EquivalentBeijing Zksk Technology Co., Ltd.accessdata.fda.gov
November 14, 2022K213217Disposable hemoclipPKLSubstantially EquivalentBeijing Zksk Technology Co., Ltd.accessdata.fda.gov
June 6, 2022K213223Multi-Band LigatorFHNSubstantially EquivalentBeijing Zksk Technology Co., Ltd.accessdata.fda.gov
June 6, 2022K213222Disposable Polypectomy SnareFDISubstantially EquivalentBeijing Zksk Technology Co., Ltd.accessdata.fda.gov
June 2, 2022K213239Endoscopic Injection NeedleFBKSubstantially EquivalentBeijing Zksk Technology Co., Ltd.accessdata.fda.gov

Compare with other makers

Updated February 6, 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.