Micro-Tech (Nanjing) Co., Ltd.
Medical device manufacturer in Nanjing, CN.
41510(k) clearances
0PMA approvals
3recalls
Device types
- PKL Hemostatic Metal Clip For The Gi Tract 8
- FGE Stents, Drains And Dilators For The Biliary… 5
- KGE Forceps, Biopsy, Electric 3
- JCT Prosthesis, Tracheal, Expandable 3
- FDI Snare, Flexible 2
- ODG Endoscopic Ultrasound System… 2
- ESW Prosthesis, Esophageal 2
- GEI Electrosurgical, Cutting & Coagulation &… 2
- SHU Appendiceal Scope And Accessories, Flexible 1
- FBK Endoscopic Injection Needle… 1
- LQR Dislodger, Stone, Biliary 1
- FBN Choledochoscope And Accessories… 1
- QSW Endoscopic Traction Device 1
- KTI Bronchoscope Accessory 1
- ODC Endoscope Channel Accessory 1
- KNS Unit, Electrosurgical, Endoscopic (With Or… 1
- PLL Submucosal Injection Agent 1
- FED Endoscopic Access Overtube, Gastroenterology… 1
- FDX Endoscopic Cytology Brush 1
- NQQ System, Imaging, Optical Coherence… 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K252492 | Visualized Access and Delivery Catheter; PB Digital ControllerSHU · Traditional | 04/24/2026SE |
| K251692 | Advanced Tissue Resection DeviceFDI · Traditional | 02/21/2026SE |
| K250229 | Dual Action Tissue Closure DevicePKL · Traditional | 09/08/2025SE |
| K243388 | Disposable Distal CapFDS · Traditional | 06/27/2025SE |
| K243471 | Extraction BasketLQR · Traditional | 12/16/2024SE |
| K230127 | Biliary Plastic Stent, Biliary Plastic Stent Introducer, Biliary Plastic Stent Set…FGE · Traditional | 09/06/2023SE |
| K221784 | Single-use Video Pancreaticobiliary Scope, PB Digital ControllerFBN · Traditional | 02/16/2023SE |
| K222354 | Elastic Traction SystemQSW · Traditional | 10/03/2022SE |
| K213060 | AreusTM Endobronchial Ultrasound Aspiration Needle, TridentTM Endobronchial Ultrasound…KTI · Traditional | 07/20/2022SE |
| K220424 | Through the Scope Tracheal Stent SystemJCT · Traditional | 07/08/2022SE |
| K220157 | Disposable Hemostatic Closure Clip DevicePKL · Traditional | 06/13/2022SE |
| K211021 | Sterile Biliary Stone Retrieval Balloon Catheter, Retrieval Balloon / short-wire…FGE · Traditional | 05/06/2022SE |
| K220247 | Guidewire Locking DeviceODC · Traditional | 03/29/2022SE |
| K212748 | Disposable Dual Action Tissue ClipPKL · Traditional | 01/20/2022SE |
| K211172 | Single Use Electrosurgical Knife with Fluid Pump SystemGEI · Traditional | 12/17/2021SE |
| K212852 | Areus(TM) Adapt Endoscopic Ultrasound Aspiration Needle, Tridemt(TM) Endoscopic…ODG · Traditional | 12/06/2021SE |
| K210934 | Sphincterotome / short-wire compatible, Sterile SphincterotomeKNS · Traditional | 12/01/2021SE |
| K212403 | Tracheal Stent System (Y-Shaped)JCT · Traditional | 10/30/2021SE |
| K202204 | Tracheal Stent SystemJCT · Traditional | 09/01/2021SE |
| K202438 | Ensure Single-Use Coagulation ForcepsKGE · Traditional | 03/15/2021SE |
| K202333 | Lockado Repositionable Hemostasis ClipPKL · Traditional | 01/14/2021SE |
| K200071 | Blue Beacon Submucosal Injectable SolutionPLL · Traditional | 11/03/2020SE |
| K193601 | Single Use Electrosurgical KnifeGEI · Traditional | 07/24/2020SE |
| K182910 | Segmented Esophageal Stent SystemESW · Traditional | 05/29/2019SE |
| K190030 | Embrella Endoscopic Distal AttachmentFED · Traditional | 03/05/2019SE |
| K182556 | SureClip Repositionable Hemostasis ClipPKL · Traditional | 12/14/2018SE |
| K180418 | Reliant(TM) Multistage Dilatation Balloon CatheterFGE · Traditional | 10/15/2018SE |
| K180018 | Disposable Hot Biopsy ForcepsKGE · Traditional | 07/05/2018SE |
| K180325 | Single Use MultiClip DevicePKL · Traditional | 06/01/2018SE |
| K172813 | Esophageal Stent SystemESW · Traditional | 05/18/2018SE |
| K172663 | Cytology BrushFDX · Traditional | 03/05/2018SE |
| K172309 | Endoscopic Ultrasound Aspiration NeedleODG · Traditional | 09/29/2017SE |
| K162226 | Reliant Multistage Dilatation Balloon CatheterFGE · Traditional | 01/25/2017SE |
| K161463 | SureClip(TM) Repositionable Hemostasis ClipPKL · Traditional | 01/06/2017SE |
| K162466 | LuminScan (TM) Imaging SystemNQQ · Traditional | 11/29/2016SE |
| K160625 | Disposable Hot Biopsy ForcepsKGE · Traditional | 06/14/2016SE |
| K152802 | Grasping ForcepsOCZ · Traditional | 01/21/2016SE |
| K152001 | Sterile Repositionable Hemostasis Clipping DevicePKL · Traditional | 12/10/2015SE |
| K151671 | Disposable Multistage Dilation Balloon CatheterFGE · Traditional | 10/16/2015SE |
| K150316 | Polypectomy SnareFDI · Traditional | 07/30/2015SE |
| K150434 | Injection NeedleFBK · Traditional | 06/02/2015SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-0237-2019 Class II | Single-Use Biopsy Forceps, JUMBO ALLIGATOR,3.2mm, REF Catalog No. NBF13-01130230, UPN…Single-Use Biopsy Forceps box contains incorrect product, instead it contains some Grasping Forceps units | 09/20/2018Terminated |
| Z-1878-2018 Class II | Trident Endoscopic Ultrasonic Aspiration Needle (FNA)The combination of the firmness of the mass, the potential endoscope and elevator position combined with the… | 03/12/2018Terminated |
| Z-1877-2018 Class II | Trident Endoscopic Ultrasonic Biopsy Needle (FNB)The combination of the firmness of the mass, the potential endoscope and elevator position combined with the… | 03/12/2018Terminated |