Micro-Tech (Nanjing) Co., Ltd. FDA Approvals

0 new drug approvals and 21 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
Visualized Access and Delivery Catheter; PB Digital Controller510(k)Apr 24, 2026Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	Apr 24, 2026
Advanced Tissue Resection Device510(k)Feb 21, 2026Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	Feb 21, 2026
Dual Action Tissue Closure Device510(k)Sep 8, 2025Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	Sep 8, 2025
Disposable Distal Cap510(k)Jun 27, 2025Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	Jun 27, 2025
Extraction Basket510(k)Dec 16, 2024Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	Dec 16, 2024
Biliary Plastic Stent, Biliary Plastic Stent Introducer, Biliary Plastic Stent Set, Biliary Plastic Stent Introducer/ short-wire compatible, Biliary Plastic Stent Set/ short-wire compatible510(k)Sep 6, 2023Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	Sep 6, 2023
Single-use Video Pancreaticobiliary Scope, PB Digital Controller510(k)Feb 16, 2023Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	Feb 16, 2023
Elastic Traction System510(k)Oct 3, 2022Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	Oct 3, 2022
AreusTM Endobronchial Ultrasound Aspiration Needle, TridentTM Endobronchial Ultrasound Aspiration Needle510(k)Jul 20, 2022Ear, Nose, Throat	Ear, Nose, Throat	510(k)Substantially Equivalent (Traditional)	Jul 20, 2022
Through the Scope Tracheal Stent System510(k)Jul 8, 2022General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Traditional)	Jul 8, 2022
Disposable Hemostatic Closure Clip Device510(k)Jun 13, 2022Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	Jun 13, 2022
Sterile Biliary Stone Retrieval Balloon Catheter, Retrieval Balloon / short-wire compatible510(k)May 6, 2022Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	May 6, 2022
Guidewire Locking Device510(k)Mar 29, 2022Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	Mar 29, 2022
Disposable Dual Action Tissue Clip510(k)Jan 20, 2022Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	Jan 20, 2022
Single Use Electrosurgical Knife with Fluid Pump System510(k)Dec 17, 2021General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Traditional)	Dec 17, 2021
Areus(TM) Adapt Endoscopic Ultrasound Aspiration Needle, Tridemt(TM) Endoscopic Ultrasound Aspiration Needle510(k)Dec 6, 2021Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	Dec 6, 2021
Sphincterotome / short-wire compatible, Sterile Sphincterotome510(k)Dec 1, 2021Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	Dec 1, 2021
Tracheal Stent System (Y-Shaped)510(k)Oct 30, 2021General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Traditional)	Oct 30, 2021
Tracheal Stent System510(k)Sep 1, 2021General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Traditional)	Sep 1, 2021
Ensure Single-Use Coagulation Forceps510(k)Mar 15, 2021Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	Mar 15, 2021
Lockado Repositionable Hemostasis Clip510(k)Jan 14, 2021Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	Jan 14, 2021

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