Company ยท CN
Micro-Tech (Nanjing) Co., Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 2015 to 2026. Name variants (Inc, Corp, punctuation) are merged.
42510(k) clearances (3 in 12 months)
3recalls (0 in 12 months)
2recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| PKL | Hemostatic Metal Clip For The Gi Tract | 8 |
| FGE | Stents, Drains And Dilators For The Biliary Ducts | 5 |
| ODG | Endoscopic Ultrasound System, Gastroenterology-Urology | 4 |
| JCT | Prosthesis, Tracheal, Expandable | 3 |
| KGE | Forceps, Biopsy, Electric | 3 |
| ESW | Prosthesis, Esophageal | 2 |
| FDI | Snare, Flexible | 2 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 2 |
| FBK | Endoscopic Injection Needle, Gastroenterology-Urology | 1 |
| FBN | Choledochoscope And Accessories, Flexible/Rigid | 1 |
| FDS | Gastroscope And Accessories, Flexible/Rigid | 1 |
| FDX | Endoscopic Cytology Brush | 1 |
| FED | Endoscopic Access Overtube, Gastroenterology-Urology | 1 |
| GEN | Forceps, General & Plastic Surgery | 1 |
| KNS | Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | 1 |
| KTI | Bronchoscope Accessory | 1 |
| LQR | Dislodger, Stone, Biliary | 1 |
| NQQ | System, Imaging, Optical Coherence Tomography (Oct) | 1 |
| OCZ | Endoscopic Grasping/Cutting Instrument, Non-Powered | 1 |
| ODC | Endoscope Channel Accessory | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 15, 2026 | K261616 | Single-Use EBUS Balloon Micro-Tech (Nanjing) Co., Ltd., CN | PSV |
| Apr 24, 2026 | K252492 | Visualized Access and Delivery Catheter; PB Digital Controller Micro-Tech (Nanjing) Co., Ltd., CN | SHU |
| Feb 21, 2026 | K251692 | Advanced Tissue Resection Device Micro-Tech (Nanjing) Co., Ltd., CN | FDI |
| Sep 8, 2025 | K250229 | Dual Action Tissue Closure Device Micro-Tech (Nanjing) Co., Ltd., CN | PKL |
| Jun 27, 2025 | K243388 | Disposable Distal Cap Micro-Tech (Nanjing) Co., Ltd., CN | FDS |
| Dec 16, 2024 | K243471 | Extraction Basket Micro-Tech (Nanjing) Co., Ltd., CN | LQR |
| Sep 6, 2023 | K230127 | Biliary Plastic Stent, Biliary Plastic Stent Introducer, Biliary Plastic Stent Set, Biliary Plastic Stent Introducer/ sh Micro-Tech (Nanjing) Co., Ltd., CN | FGE |
| Feb 16, 2023 | K221784 | Single-use Video Pancreaticobiliary Scope, PB Digital Controller Micro-Tech (Nanjing) Co., Ltd., CN | FBN |
| Oct 3, 2022 | K222354 | Elastic Traction System Micro-Tech (Nanjing) Co., Ltd., CN | QSW |
| Jul 20, 2022 | K213060 | AreusTM Endobronchial Ultrasound Aspiration Needle, TridentTM Endobronchial Ultrasound Aspiration Needle Micro-Tech (Nanjing) Co., Ltd., CN | KTI |
| Jul 8, 2022 | K220424 | Through the Scope Tracheal Stent System Micro-Tech (Nanjing) Co., Ltd., CN | JCT |
| Jun 13, 2022 | K220157 | Disposable Hemostatic Closure Clip Device Micro-Tech (Nanjing) Co., Ltd., CN | PKL |
| May 6, 2022 | K211021 | Sterile Biliary Stone Retrieval Balloon Catheter, Retrieval Balloon / short-wire compatible Micro-Tech (Nanjing) Co., Ltd., CN | FGE |
| Mar 29, 2022 | K220247 | Guidewire Locking Device Micro-Tech (Nanjing) Co., Ltd., CN | ODC |
| Jan 20, 2022 | K212748 | Disposable Dual Action Tissue Clip Micro-Tech (Nanjing) Co., Ltd., CN | PKL |
| Dec 17, 2021 | K211172 | Single Use Electrosurgical Knife with Fluid Pump System Micro-Tech (Nanjing) Co., Ltd., CN | GEI |
| Dec 6, 2021 | K212852 | Areus(TM) Adapt Endoscopic Ultrasound Aspiration Needle, Tridemt(TM) Endoscopic Ultrasound Aspiration Needle Micro-Tech (Nanjing) Co., Ltd., CN | ODG |
| Dec 1, 2021 | K210934 | Sphincterotome / short-wire compatible, Sterile Sphincterotome Micro-Tech (Nanjing) Co., Ltd., CN | KNS |
| Oct 30, 2021 | K212403 | Tracheal Stent System (Y-Shaped) Micro-Tech (Nanjing) Co., Ltd., CN | JCT |
| Sep 1, 2021 | K202204 | Tracheal Stent System Micro-Tech (Nanjing) Co., Ltd., CN | JCT |
| Mar 15, 2021 | K202438 | Ensure Single-Use Coagulation Forceps Micro-Tech (Nanjing) Co., Ltd., CN | KGE |
| Jan 14, 2021 | K202333 | Lockado Repositionable Hemostasis Clip Micro-Tech (Nanjing) Co., Ltd., CN | PKL |
| Nov 3, 2020 | K200071 | Blue Beacon Submucosal Injectable Solution Micro-Tech (Nanjing) Co., Ltd., CN | PLL |
| Jul 24, 2020 | K193601 | Single Use Electrosurgical Knife Micro-Tech (Nanjing) Co., Ltd., CN | GEI |
| May 29, 2019 | K182910 | Segmented Esophageal Stent System Micro-Tech (Nanjing) Co., Ltd., CN | ESW |
| Mar 5, 2019 | K190030 | Embrella Endoscopic Distal Attachment Micro-Tech (Nanjing) Co., Ltd., CN | FED |
| Dec 14, 2018 | K182556 | SureClip Repositionable Hemostasis Clip Micro-Tech (Nanjing) Co., Ltd., CN | PKL |
| Oct 15, 2018 | K180418 | Reliant(TM) Multistage Dilatation Balloon Catheter Micro-Tech (Nanjing) Co., Ltd., CN | FGE |
| Jul 5, 2018 | K180018 | Disposable Hot Biopsy Forceps Micro-Tech (Nanjing) Co., Ltd., CN | KGE |
| Jun 1, 2018 | K180325 | Single Use MultiClip Device Micro-Tech (Nanjing) Co., Ltd., CN | PKL |
| May 18, 2018 | K172813 | Esophageal Stent System Micro-Tech (Nanjing) Co., Ltd., CN | ESW |
| Mar 5, 2018 | K172663 | Cytology Brush Micro-Tech (Nanjing) Co., Ltd., CN | FDX |
| Sep 29, 2017 | K172309 | Endoscopic Ultrasound Aspiration Needle Micro-Tech (Nanjing) Co., Ltd., CN | ODG |
| Jan 25, 2017 | K162226 | Reliant Multistage Dilatation Balloon Catheter Micro-Tech (Nanjing) Co., Ltd., CN | FGE |
| Jan 6, 2017 | K161463 | SureClip(TM) Repositionable Hemostasis Clip Micro-Tech (Nanjing) Co., Ltd., CN | PKL |
| Nov 29, 2016 | K162466 | LuminScan (TM) Imaging System Micro-Tech (Nanjing) Co., Ltd., CN | NQQ |
| Jun 14, 2016 | K160625 | Disposable Hot Biopsy Forceps Micro-Tech (Nanjing) Co., Ltd., CN | KGE |
| Jan 21, 2016 | K152802 | Grasping Forceps Micro-Tech (Nanjing) Co., Ltd., CN | OCZ |
| Dec 10, 2015 | K152001 | Sterile Repositionable Hemostasis Clipping Device Micro-Tech (Nanjing) Co., Ltd., CN | PKL |
| Oct 16, 2015 | K151671 | Disposable Multistage Dilation Balloon Catheter Micro-Tech (Nanjing) Co., Ltd., CN | FGE |
| Jul 30, 2015 | K150316 | Polypectomy Snare Micro-Tech (Nanjing) Co., Ltd., CN | FDI |
| Jun 2, 2015 | K150434 | Injection Needle Micro-Tech (Nanjing) Co., Ltd., CN | FBK |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 20, 2018 | Micro-Tech (Nanjing) Co., Ltd. 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 Terminated |
GEN | None listed |
| Mar 12, 2018 | Micro-Tech (Nanjing) Co., Ltd. Trident Endoscopic Ultrasonic Aspiration Needle (FNA) Terminated |
ODG | K172309 |
| Mar 12, 2018 | Micro-Tech (Nanjing) Co., Ltd. Trident Endoscopic Ultrasonic Biopsy Needle (FNB) Terminated |
ODG | K172309 |