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Data / Medical devices / China / Micro-Tech (Nanjing) Co., Ltd.

Micro-Tech (Nanjing) Co., Ltd.: FDA-registered device maker in NAN JING Jiangsu, China, 44 510(k) clearances

Micro-Tech (Nanjing) Co., Ltd. is registered with the FDA (registration 3004837686) in NAN JING Jiangsu, China. It lists 47 device types. The FDA files 44 510(k) clearances under its listings, the newest dated October 15, 2026. 2 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Micro-Tech (Nanjing) Co., Ltd.
FDA registration number
3004837686
Address
NO.10 Gaoke Third Road,Nanjing National Hi-Tech Industrial Development Zone Nanjing 210032,Jiangsu Province,PRC, NAN JING Jiangsu, China, 210032
Owner or operator
Micro-Tech (Nanjing) Co., Ltd. (9067602)
Roles
Contract manufacturer, Manufacturer
First device listed
October 25, 2004
Registered through
2027
Brand names listed
ABC Dilatation Balloon Catheter, ADVANTIS™ Polypectomy Snare, Additional Working Channel, Areus™ Adapt Endoscopic Ultrasound Aspiration Needle, Areus™ Endobronchial Ultrasound Aspiration Needle, Areus™ Endoscopic Ultrasound Aspiration Needle(FNA), Biliary Plastic Stent, Biliary Plastic Stent Introducer and more

Devices it lists

DeviceProduct codeClassRoleSource
Accessories, Cleaning Brushes, For EndoscopeMNL1Manufactureraccessdata.fda.gov
Adaptor, CatheterGCE1Manufactureraccessdata.fda.gov
Appendiceal Scope And Accessories, FlexibleSHU2Manufactureraccessdata.fda.gov
Bedding, Disposable, MedicalKME1Manufactureraccessdata.fda.gov
Biopsy NeedleFCG2Manufactureraccessdata.fda.gov
Bottle, Collection, VacuumKDQ2Manufactureraccessdata.fda.gov
Bronchoscope (Flexible Or Rigid)EOQ2Manufactureraccessdata.fda.gov
Bronchoscope AccessoryKTI2Manufactureraccessdata.fda.gov
Camera, Surgical And AccessoriesKQM1Manufactureraccessdata.fda.gov
Choledochoscope And Accessories, Flexible/RigidFBN2Manufactureraccessdata.fda.gov
Dilator, EsophagealKNQ2Manufactureraccessdata.fda.gov
Dislodger, Stone, BiliaryLQR2Manufactureraccessdata.fda.gov
Electrosurgical, Cutting & Coagulation & AccessoriesGEI2Manufactureraccessdata.fda.gov
Endoscope Channel AccessoryODC2Manufactureraccessdata.fda.gov
Endoscopic Access Overtube, Gastroenterology-UrologyFED2Manufactureraccessdata.fda.gov
Endoscopic Bite BlockMNK1Manufactureraccessdata.fda.gov
Endoscopic Cytology BrushFDX2Manufactureraccessdata.fda.gov
Endoscopic Grasping/Cutting Instrument, Non-PoweredOCZ2Manufactureraccessdata.fda.gov
Endoscopic Grasping/Cutting Instrument, Non-Powered, ExemptPTS2Manufactureraccessdata.fda.gov
Endoscopic Guidewire, Gastroenterology-UrologyOCY2Manufactureraccessdata.fda.gov
Endoscopic Injection Needle, Gastroenterology-UrologyFBK2Manufactureraccessdata.fda.gov
Endoscopic Traction DeviceQSW2Manufactureraccessdata.fda.gov
Endoscopic Ultrasound System, Gastroenterology-UrologyODG2Contract manufacturer, Manufactureraccessdata.fda.gov
Endoscopic Video Imaging System/Component, Gastroenterology-UrologyFET2Manufactureraccessdata.fda.gov
Forceps, Biopsy, ElectricKGE2Manufactureraccessdata.fda.gov
Forceps, Biopsy, Non-ElectricFCL1Manufactureraccessdata.fda.gov
Gastroscope And Accessories, Flexible/RigidFDS2Manufactureraccessdata.fda.gov
Guide, Surgical, InstrumentFZX1Manufactureraccessdata.fda.gov
Hemostatic Metal Clip For The Gi TractPKL2Manufactureraccessdata.fda.gov
Instrument, Manual, Surgical, General UseMDM1Manufactureraccessdata.fda.gov
Lavage, JetFQH2Manufactureraccessdata.fda.gov
Led Light SourceNTN2Manufactureraccessdata.fda.gov
Ligator, EsophagealMND2Manufactureraccessdata.fda.gov
Ligator, HemorrhoidalFHN2Manufactureraccessdata.fda.gov
Marker, ColonNBG2Manufactureraccessdata.fda.gov
Prosthesis, EsophagealESW2Manufactureraccessdata.fda.gov
Prosthesis, Tracheal, ExpandableJCT2Manufactureraccessdata.fda.gov
Snare, FlexibleFDI2Manufactureraccessdata.fda.gov
Snare, Non-ElectricalFGX1Manufactureraccessdata.fda.gov
Snare, SurgicalGAE1Manufactureraccessdata.fda.gov
Stents, Drains And Dilators For The Biliary DuctsFGE2Manufactureraccessdata.fda.gov
Submucosal Injection AgentPLL2Manufactureraccessdata.fda.gov
Syringe, Balloon Inflation, ExemptPTM2Manufactureraccessdata.fda.gov
System, Imaging, Optical Coherence Tomography (Oct)NQQ2Manufactureraccessdata.fda.gov
Tape, Measuring, Rulers And CalipersFTY1Manufactureraccessdata.fda.gov
Ultrasound BronchoscopePSV2Manufactureraccessdata.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
October 15, 2026K261616Single-Use EBUS BalloonPSVSubstantially EquivalentMicro-Tech (Nanjing) Co., Ltd.accessdata.fda.gov
May 29, 2026K260262Injection NeedleFBKSubstantially EquivalentMirco-Tech (Nanjing) Co., Ltd.accessdata.fda.gov
April 24, 2026K253832Dilation Balloon CatheterFGESubstantially EquivalentMirco-Tech (Nanjing) Co., Ltd.accessdata.fda.gov
April 24, 2026K252492Visualized Access and Delivery Catheter; PB Digital ControllerSHUSubstantially EquivalentMicro-Tech (Nanjing) Co., Ltd.accessdata.fda.gov
April 3, 2026K254153Single-use Video Scope; PB Digital ControllerFBNSubstantially EquivalentMirco-Tech (Nanjing) Co., Ltd.accessdata.fda.gov
March 19, 2026K253139Disposable Distal CapFBNSubstantially EquivalentMirco-Tech (Nanjing) Co., Ltd.accessdata.fda.gov
February 21, 2026K251692Advanced Tissue Resection DeviceFDISubstantially EquivalentMicro-Tech (Nanjing) Co., Ltd.accessdata.fda.gov
September 8, 2025K250229Dual Action Tissue Closure DevicePKLSubstantially EquivalentMicro-Tech (Nanjing) Co., Ltd.accessdata.fda.gov
June 27, 2025K243388Disposable Distal CapFDSSubstantially EquivalentMicro-Tech (Nanjing) Co., Ltd.accessdata.fda.gov
December 16, 2024K243471Extraction BasketLQRSubstantially EquivalentMicro-Tech (Nanjing) Co., Ltd.accessdata.fda.gov
March 19, 2024K233772Disposable Dual Action Tissue Closure DevicePKLSubstantially EquivalentMirco-Tech (Nanjing) Co., Ltd.accessdata.fda.gov
September 6, 2023K230127Biliary Plastic Stent, Biliary Plastic Stent Introducer, Biliary Plastic Stent Set, Biliary Plastic Stent Introducer/ short-wire compatible, Biliary Plastic Stent Set/ short-wire compatibleFGESubstantially EquivalentMicro-Tech (Nanjing) Co., Ltd.accessdata.fda.gov
February 16, 2023K221784Single-use Video Pancreaticobiliary Scope, PB Digital ControllerFBNSubstantially EquivalentMicro-Tech (Nanjing) Co., Ltd.accessdata.fda.gov
October 3, 2022K222354Elastic Traction SystemQSWSubstantially EquivalentMicro-Tech (Nanjing) Co., Ltd.accessdata.fda.gov
July 20, 2022K213060AreusTM Endobronchial Ultrasound Aspiration Needle, TridentTM Endobronchial Ultrasound Aspiration NeedleKTISubstantially EquivalentMicro-Tech (Nanjing) Co., Ltd.accessdata.fda.gov
July 8, 2022K220424Through the Scope Tracheal Stent SystemJCTSubstantially EquivalentMicro-Tech (Nanjing) Co., Ltd.accessdata.fda.gov
July 8, 2022K213782Single-Use Video Bronchoscopes, Digital ControllerEOQSubstantially EquivalentMicro-Tech (Nanjing) Co., Ltsaccessdata.fda.gov
June 13, 2022K220157Disposable Hemostatic Closure Clip DevicePKLSubstantially EquivalentMicro-Tech (Nanjing) Co., Ltd.accessdata.fda.gov
May 6, 2022K211021Sterile Biliary Stone Retrieval Balloon Catheter, Retrieval Balloon / short-wire compatibleFGESubstantially EquivalentMicro-Tech (Nanjing) Co., Ltd.accessdata.fda.gov
March 29, 2022K220247Guidewire Locking DeviceODCSubstantially EquivalentMicro-Tech (Nanjing) Co., Ltd.accessdata.fda.gov
January 20, 2022K212748Disposable Dual Action Tissue ClipPKLSubstantially EquivalentMicro-Tech (Nanjing) Co., Ltd.accessdata.fda.gov
December 17, 2021K211172Single Use Electrosurgical Knife with Fluid Pump SystemGEISubstantially EquivalentMicro-Tech (Nanjing) Co., Ltd.accessdata.fda.gov
December 6, 2021K212852Areus(TM) Adapt Endoscopic Ultrasound Aspiration Needle, Tridemt(TM) Endoscopic Ultrasound Aspiration NeedleODGSubstantially EquivalentMicro-Tech (Nanjing) Co., Ltd.accessdata.fda.gov
December 1, 2021K210934Sphincterotome / short-wire compatible, Sterile SphincterotomeKNSSubstantially EquivalentMicro-Tech (Nanjing) Co., Ltd.accessdata.fda.gov
October 30, 2021K212403Tracheal Stent System (Y-Shaped)JCTSubstantially EquivalentMicro-Tech (Nanjing) Co., Ltd.accessdata.fda.gov
September 1, 2021K202204Tracheal Stent SystemJCTSubstantially EquivalentMicro-Tech (Nanjing) Co., Ltd.accessdata.fda.gov
March 15, 2021K202438Ensure Single-Use Coagulation ForcepsKGESubstantially EquivalentMicro-Tech (Nanjing) Co., Ltd.accessdata.fda.gov
January 14, 2021K202333Lockado Repositionable Hemostasis ClipPKLSubstantially EquivalentMicro-Tech (Nanjing) Co., Ltd.accessdata.fda.gov
November 3, 2020K200071Blue Beacon Submucosal Injectable SolutionPLLSubstantially EquivalentMicro-Tech (Nanjing) Co., Ltd.accessdata.fda.gov
July 24, 2020K193601Single Use Electrosurgical KnifeGEISubstantially EquivalentMicro-Tech (Nanjing) Co., Ltd.accessdata.fda.gov
May 29, 2019K182910Segmented Esophageal Stent SystemESWSubstantially EquivalentMicro-Tech (Nanjing) Co., Ltd.accessdata.fda.gov
March 5, 2019K190030Embrella Endoscopic Distal AttachmentFEDSubstantially EquivalentMicro-Tech (Nanjing) Co., Ltd.accessdata.fda.gov
December 14, 2018K182556SureClip Repositionable Hemostasis ClipPKLSubstantially EquivalentMicro-Tech (Nanjing) Co., Ltd.accessdata.fda.gov
October 15, 2018K180418Reliant(TM) Multistage Dilatation Balloon CatheterFGESubstantially EquivalentMicro-Tech (Nanjing) Co., Ltd.accessdata.fda.gov
July 5, 2018K180018Disposable Hot Biopsy ForcepsKGESubstantially EquivalentMicro-Tech (Nanjing) Co., Ltd.accessdata.fda.gov
June 1, 2018K180325Single Use MultiClip DevicePKLSubstantially EquivalentMicro-Tech (Nanjing) Co., Ltd.accessdata.fda.gov
May 18, 2018K172813Esophageal Stent SystemESWSubstantially EquivalentMicro-Tech (Nanjing) Co., Ltd.accessdata.fda.gov
March 5, 2018K172663Cytology BrushFDXSubstantially EquivalentMicro-Tech (Nanjing) Co., Ltd.accessdata.fda.gov
September 29, 2017K172309Endoscopic Ultrasound Aspiration NeedleODGSubstantially EquivalentMicro-Tech (Nanjing) Co., Ltd.accessdata.fda.gov
January 6, 2017K161463SureClip(TM) Repositionable Hemostasis ClipPKLSubstantially EquivalentMicro-Tech (Nanjing) Co., Ltd.accessdata.fda.gov
November 29, 2016K162466LuminScan (TM) Imaging SystemNQQSubstantially EquivalentMicro-Tech (Nanjing) Co., Ltd.accessdata.fda.gov
January 21, 2016K152802Grasping ForcepsOCZSubstantially EquivalentMicro-Tech (Nanjing) Co., Ltd.accessdata.fda.gov
July 30, 2015K150316Polypectomy SnareFDISubstantially EquivalentMicro-Tech (Nanjing) Co., Ltd.accessdata.fda.gov
June 2, 2015K150434Injection NeedleFBKSubstantially EquivalentMicro-Tech (Nanjing) Co., Ltd.accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

InitiatedEventClassStatusProductReasonSource
September 20, 201881176Class IITerminatedSingle-Use Biopsy Forceps, JUMBO ALLIGATOR,3.2mm, REF Catalog No. NBF13-01130230, UPN BF40180 (Pouch level) - BF40181(Case box level) BF40182 (Carton box level) - BF40183(Over shipper level), STERILESingle-Use Biopsy Forceps box contains incorrect product, instead it contains some Grasping Forceps unitsaccessdata.fda.gov
March 12, 201879911Class IITerminatedTrident Endoscopic Ultrasonic Biopsy Needle (FNB)The combination of the firmness of the mass, the potential endoscope and elevator position combined with the force required to penetrate the mass may contribute to the breakage of the needle in the human body, which could cause injury.accessdata.fda.gov

Compare with other makers

Updated October 15, 2026. 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.