Micro-Tech (Nanjing) Co., Ltd.
FDA Regulatory Profile
Summary
- Total Recalls
- 3
- 510(k) Clearances
- 40
- Inspections
- 1
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0237-2019 | Class II | Single-Use Biopsy Forceps, JUMBO ALLIGATOR,3.2mm, REF Catalog No. NBF13-01130230, UPN BF40180 (Pouc | September 20, 2018 |
| Z-1878-2018 | Class II | Trident Endoscopic Ultrasonic Aspiration Needle (FNA) | March 12, 2018 |
| Z-1877-2018 | Class II | Trident Endoscopic Ultrasonic Biopsy Needle (FNB) | March 12, 2018 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K251692 | Advanced Tissue Resection Device | February 21, 2026 |
| K250229 | Dual Action Tissue Closure Device | September 8, 2025 |
| K243388 | Disposable Distal Cap | June 27, 2025 |
| K243471 | Extraction Basket | December 16, 2024 |
| K230127 | Biliary Plastic Stent, Biliary Plastic Stent Introducer, Biliary Plastic Stent Set, Biliary Plastic | September 6, 2023 |
| K221784 | Single-use Video Pancreaticobiliary Scope, PB Digital Controller | February 16, 2023 |
| K222354 | Elastic Traction System | October 3, 2022 |
| K213060 | AreusTM Endobronchial Ultrasound Aspiration Needle, TridentTM Endobronchial Ultrasound Aspiration Ne | July 20, 2022 |
| K220424 | Through the Scope Tracheal Stent System | July 8, 2022 |
| K220157 | Disposable Hemostatic Closure Clip Device | June 13, 2022 |
| K211021 | Sterile Biliary Stone Retrieval Balloon Catheter, Retrieval Balloon / short-wire compatible | May 6, 2022 |
| K220247 | Guidewire Locking Device | March 29, 2022 |
| K212748 | Disposable Dual Action Tissue Clip | January 20, 2022 |
| K211172 | Single Use Electrosurgical Knife with Fluid Pump System | December 17, 2021 |
| K212852 | Areus(TM) Adapt Endoscopic Ultrasound Aspiration Needle, Tridemt(TM) Endoscopic Ultrasound Aspiratio | December 6, 2021 |
| K210934 | Sphincterotome / short-wire compatible, Sterile Sphincterotome | December 1, 2021 |
| K212403 | Tracheal Stent System (Y-Shaped) | October 30, 2021 |
| K202204 | Tracheal Stent System | September 1, 2021 |
| K202438 | Ensure Single-Use Coagulation Forceps | March 15, 2021 |
| K202333 | Lockado Repositionable Hemostasis Clip | January 14, 2021 |