Micro-Tech (Nanjing) Co., Ltd.
NAN JING Jiangsu, CN
Micro-Tech (Nanjing) Co., Ltd. appears in FDA device records in NAN JING Jiangsu, CN. FDA records list 41 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show 3 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 41 510(k) clearances for Micro-Tech (Nanjing) Co., Ltd. between 2015 and 2026. The busiest year on record is 2021, with 7. The most recent is 2026, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2015 | 4 |
| 2016 | 3 |
| 2017 | 3 |
| 2018 | 6 |
| 2019 | 2 |
| 2020 | 2 |
| 2021 | 7 |
| 2022 | 7 |
| 2023 | 2 |
| 2024 | 1 |
| 2025 | 2 |
| 2026 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K252492 | Visualized Access and Delivery Catheter; PB Digital Controller | SHU | Substantially Equivalent | |
| K251692 | Advanced Tissue Resection Device | FDI | Substantially Equivalent | |
| K250229 | Dual Action Tissue Closure Device | PKL | Substantially Equivalent | |
| K243388 | Disposable Distal Cap | FDS | Substantially Equivalent | |
| K243471 | Extraction Basket | LQR | Substantially Equivalent | |
| K230127 | Biliary Plastic Stent, Biliary Plastic Stent Introducer, Biliary Plastic Stent Set, Biliary Plastic Stent Introducer/ short-wire compatible, Biliary Plastic Stent Set/ short-wire compatible | FGE | Substantially Equivalent | |
| K221784 | Single-use Video Pancreaticobiliary Scope, PB Digital Controller | FBN | Substantially Equivalent | |
| K222354 | Elastic Traction System | QSW | Substantially Equivalent | |
| K213060 | AreusTM Endobronchial Ultrasound Aspiration Needle, TridentTM Endobronchial Ultrasound Aspiration Needle | KTI | Substantially Equivalent | |
| K220424 | Through the Scope Tracheal Stent System | JCT | Substantially Equivalent | |
| K220157 | Disposable Hemostatic Closure Clip Device | PKL | Substantially Equivalent | |
| K211021 | Sterile Biliary Stone Retrieval Balloon Catheter, Retrieval Balloon / short-wire compatible | FGE | Substantially Equivalent | |
| K220247 | Guidewire Locking Device | ODC | Substantially Equivalent | |
| K212748 | Disposable Dual Action Tissue Clip | PKL | Substantially Equivalent | |
| K211172 | Single Use Electrosurgical Knife with Fluid Pump System | GEI | Substantially Equivalent | |
| K212852 | Areus(TM) Adapt Endoscopic Ultrasound Aspiration Needle, Tridemt(TM) Endoscopic Ultrasound Aspiration Needle | ODG | Substantially Equivalent | |
| K210934 | Sphincterotome / short-wire compatible, Sterile Sphincterotome | KNS | Substantially Equivalent | |
| K212403 | Tracheal Stent System (Y-Shaped) | JCT | Substantially Equivalent | |
| K202204 | Tracheal Stent System | JCT | Substantially Equivalent | |
| K202438 | Ensure Single-Use Coagulation Forceps | KGE | Substantially Equivalent | |
| K202333 | Lockado Repositionable Hemostasis Clip | PKL | Substantially Equivalent | |
| K200071 | Blue Beacon Submucosal Injectable Solution | PLL | Substantially Equivalent | |
| K193601 | Single Use Electrosurgical Knife | GEI | Substantially Equivalent | |
| K182910 | Segmented Esophageal Stent System | ESW | Substantially Equivalent | |
| K190030 | Embrella Endoscopic Distal Attachment | FED | Substantially Equivalent | |
| K182556 | SureClip Repositionable Hemostasis Clip | PKL | Substantially Equivalent | |
| K180418 | Reliant(TM) Multistage Dilatation Balloon Catheter | FGE | Substantially Equivalent | |
| K180018 | Disposable Hot Biopsy Forceps | KGE | Substantially Equivalent | |
| K180325 | Single Use MultiClip Device | PKL | Substantially Equivalent | |
| K172813 | Esophageal Stent System | ESW | Substantially Equivalent | |
| K172663 | Cytology Brush | FDX | Substantially Equivalent | |
| K172309 | Endoscopic Ultrasound Aspiration Needle | ODG | Substantially Equivalent | |
| K162226 | Reliant Multistage Dilatation Balloon Catheter | FGE | Substantially Equivalent | |
| K161463 | SureClip(TM) Repositionable Hemostasis Clip | PKL | Substantially Equivalent | |
| K162466 | LuminScan (TM) Imaging System | NQQ | Substantially Equivalent | |
| K160625 | Disposable Hot Biopsy Forceps | KGE | Substantially Equivalent | |
| K152802 | Grasping Forceps | OCZ | Substantially Equivalent | |
| K152001 | Sterile Repositionable Hemostasis Clipping Device | PKL | Substantially Equivalent | |
| K151671 | Disposable Multistage Dilation Balloon Catheter | FGE | Substantially Equivalent | |
| K150316 | Polypectomy Snare | FDI | Substantially Equivalent | |
| K150434 | Injection Needle | FBK | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3004837686 | 3004837686 | Micro-Tech (Nanjing) Co., Ltd. | NO.10 Gaoke Third Road,Nanjing National Hi-Tech Industrial Development Zone, NAN JING Jiangsu 210032 CN | 2026 | and 36 more, listed in full below |
| 3013440400 | 3013440400 | Micro-Tech (Nanjing) Co., Ltd. | No. 199 Medicine Valley Avenue, Nanjing National Hi-Tech, Nanjing Jiangsu 210032 CN | 2026 | and 39 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- MNLAccessories, Cleaning Brushes, For Endoscope
- GCEAdaptor, Catheter
- SHUAppendiceal Scope And Accessories, Flexible
- KMEBedding, Disposable, Medical
- FCGBiopsy Needle
- KDQBottle, Collection, Vacuum
- EOQBronchoscope (Flexible Or Rigid)
- KTIBronchoscope Accessory
- KQMCamera, Surgical And Accessories
- FBNCholedochoscope And Accessories, Flexible/Rigid
- KNQDilator, Esophageal
- LQRDislodger, Stone, Biliary
- GEIElectrosurgical, Cutting & Coagulation & Accessories
- ODCEndoscope Channel Accessory
- FEDEndoscopic Access Overtube, Gastroenterology-Urology
- MNKEndoscopic Bite Block
- FDXEndoscopic Cytology Brush
- OCZEndoscopic Grasping/Cutting Instrument, Non-Powered
- PTSEndoscopic Grasping/Cutting Instrument, Non-Powered, Exempt
- OCYEndoscopic Guidewire, Gastroenterology-Urology
- FBKEndoscopic Injection Needle, Gastroenterology-Urology
- QSWEndoscopic Traction Device
- ODGEndoscopic Ultrasound System, Gastroenterology-Urology
- FETEndoscopic Video Imaging System/Component, Gastroenterology-Urology
- KGEForceps, Biopsy, Electric
- FCLForceps, Biopsy, Non-Electric
- FDSGastroscope And Accessories, Flexible/Rigid
- FZXGuide, Surgical, Instrument
- PKLHemostatic Metal Clip For The Gi Tract
- KNWInstrument, Biopsy
- MDMInstrument, Manual, Surgical, General Use
- FQHLavage, Jet
- NTNLed Light Source
- MNDLigator, Esophageal
- FHNLigator, Hemorrhoidal
- NBGMarker, Colon
- MIJNeedle, Tumor Localization
- ESWProsthesis, Esophageal
- JCTProsthesis, Tracheal, Expandable
- FDISnare, Flexible
- FGXSnare, Non-Electrical
- GAESnare, Surgical
- FGEStents, Drains And Dilators For The Biliary Ducts
- PLLSubmucosal Injection Agent
- PTMSyringe, Balloon Inflation, Exempt
- NEYSystem, Ablation, Microwave And Accessories
- NQQSystem, Imaging, Optical Coherence Tomography (Oct)
- FTYTape, Measuring, Rulers And Calipers
- KNSUnit, Electrosurgical, Endoscopic (With Or Without Accessories)
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0237-2019 | Single-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), STERILE | Single-Use Biopsy Forceps box contains incorrect product, instead it contains some Grasping Forceps units | Class II | Terminated | |
| Z-1878-2018 | Trident Endoscopic Ultrasonic Aspiration Needle (FNA) | 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. | Class II | Terminated | |
| Z-1877-2018 | Trident 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. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain