Medical Device Manufacturer · CN , Nanjing

Micro-Tech (Nanjing) Co., Ltd.

40 submissions · 40 cleared · Since 2015
40
Total
40
Cleared
0
Denied

Micro-Tech (Nanjing) Co., Ltd. — FDA 510(k) Submissions

Micro-Tech (Nanjing) Co., Ltd. has submitted 40 FDA 510(k) premarket notifications since 2015, of which 40 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Hemostatic Metal Clip For The Gi Tract, Stents, Drains And Dilators For The Biliary Ducts, Prosthesis, Tracheal, Expandable, Forceps, Biopsy, Electric, Snare, Flexible . Use the specialty filter in the sidebar to narrow results.

40 devices
1–25 of 40
Advanced Tissue Resection Device
K251692 · FDI Snare, Flexible · Gastroenterology & Urology
Feb 2026 264d
Dual Action Tissue Closure Device
K250229 · PKL Hemostatic Metal Clip For... · Gastroenterology & Urology
Sep 2025 224d
Disposable Distal Cap
K243388 · FDS Gastroscope And... · Gastroenterology & Urology
Jun 2025 239d
Extraction Basket
K243471 · LQR Dislodger, Stone, Biliary · Gastroenterology & Urology
Dec 2024 38d
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
K230127 · FGE Stents, Drains And... · Gastroenterology & Urology
Sep 2023 232d
Single-use Video Pancreaticobiliary Scope, PB Digital Controller
K221784 · FBN Choledochoscope And... · Gastroenterology & Urology
Feb 2023 240d
Elastic Traction System
K222354 · QSW Endoscopic Traction Device · Gastroenterology & Urology
Oct 2022 60d
AreusTM Endobronchial Ultrasound Aspiration Needle, TridentTM Endobronchial Ultrasound Aspiration Needle
K213060 · KTI Bronchoscope Accessory · Anesthesiology
Jul 2022 301d
Through the Scope Tracheal Stent System
K220424 · JCT Prosthesis, Tracheal,... · Anesthesiology
Jul 2022 144d
Disposable Hemostatic Closure Clip Device
K220157 · PKL Hemostatic Metal Clip For... · Gastroenterology & Urology
Jun 2022 145d
Sterile Biliary Stone Retrieval Balloon Catheter, Retrieval Balloon / short-wire compatible
K211021 · FGE Stents, Drains And... · Gastroenterology & Urology
May 2022 396d
Guidewire Locking Device
K220247 · ODC Endoscope Channel Accessory · Gastroenterology & Urology
Mar 2022 60d
Disposable Dual Action Tissue Clip
K212748 · PKL Hemostatic Metal Clip For... · Gastroenterology & Urology
Jan 2022 143d
Single Use Electrosurgical Knife with Fluid Pump System
K211172 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Dec 2021 242d
Areus(TM) Adapt Endoscopic Ultrasound Aspiration Needle, Tridemt(TM) Endoscopic Ultrasound Aspiration Needle
K212852 · ODG Endoscopic Ultrasound... · Gastroenterology & Urology
Dec 2021 90d
Sphincterotome / short-wire compatible, Sterile Sphincterotome
K210934 · KNS Unit, Electrosurgical,... · Gastroenterology & Urology
Dec 2021 247d
Tracheal Stent System (Y-Shaped)
K212403 · JCT Prosthesis, Tracheal,... · Anesthesiology
Oct 2021 89d
Tracheal Stent System
K202204 · JCT Prosthesis, Tracheal,... · Anesthesiology
Sep 2021 392d
Ensure Single-Use Coagulation Forceps
K202438 · KGE Forceps, Biopsy, Electric · Gastroenterology & Urology
Mar 2021 202d
Lockado Repositionable Hemostasis Clip
K202333 · PKL Hemostatic Metal Clip For... · Gastroenterology & Urology
Jan 2021 150d
Blue Beacon Submucosal Injectable Solution
K200071 · PLL Submucosal Injection Agent · Gastroenterology & Urology
Nov 2020 295d
Single Use Electrosurgical Knife
K193601 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Jul 2020 214d
Segmented Esophageal Stent System
K182910 · ESW Prosthesis, Esophageal · Gastroenterology & Urology
May 2019 224d
Embrella Endoscopic Distal Attachment
K190030 · FED Endoscopic Access... · Gastroenterology & Urology
Mar 2019 57d
SureClip Repositionable Hemostasis Clip
K182556 · PKL Hemostatic Metal Clip For... · Gastroenterology & Urology
Dec 2018 88d
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