Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004837686

FEI Number

3004837686

Entity Name

Micro-Tech (Nanjing) Co., Ltd.

City/State/Country

NAN JING Jiangsu, CN

Establishment Address

NO.10 Gaoke Third Road,Nanjing National Hi-Tech Industrial Development Zone, Nanjing 210032,Jiangsu Province,PRC, NAN JING Jiangsu 210032, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Micro-Tech (Nanjing) Co., Ltd. (Owner Number: 9067602)

Owner / Operator Contact Address

No.10, Gaoke Third Road, Nanjing National Hi-Tech Industrial Development Zone, Nanjing, CN-JS 210032, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Disposable Dual Action Tissue Closure Device Esophageal Stent System Disposable Distal Cap Visor Cap Disposable Distal Cap Areus Endobronchial Ultrasound Aspiration Needle Trident Endobronchial Ultrasound Aspiration Needle LesionHunter Rotatable Nitinol Cold Snare Cold Snare Embrella(TM) Endoscopic Distal Attachment Dual Action Tissue Closure Device (DAT Slim) Areus (TM) Adapt Endoscopic Ultrasound Aspiration Needle Trident (TM) Adapt Endoscopic Ultrasound Biopsy Needle Ensure(TM) Single-Use Coagulation Forceps Injection Needle Pinpoint Injection Needle Ultrasound Disposable Kits Hemorrhoid Multiple Band Ligator Set SureFire Multiple Band Ligator Set Injection Needle Ensure(TM) Single-Use Coagulation Forceps Disposble Bite Block EnTrap(TM) Polyp Retrieval Snare Net Polypectomy Snare EdgeHog(TM) Polypectomy Snare Biliary Plastic Stent Set/ short-wire compatible Biliary Plastic Stent Set Biliary Plastic Stent Biliary Plastic Stent Introducer/ short-wire compatible Biliary Plastic Stent Introducer Guidewire Locking Device Polyp Collection Kit Cytology Brush eyeMAX slim Single-use Video Scope PB Digital Controller SureClip(R) Repositionable Hemostasis Clip CatchAll(TM) Transport Pad Single Use MultiClip Device Napoleon(TM) Endoscopic Polyp Measurement Device Single Use Electrosurgical Knife Single Use Electrosurgical Knife Fluid Pump System S.T.A.R (TM) Disposable Hemostatic Closure Clip Device RiteClip(TM) Repositionable Hemostasis Clip Disposable Inflation Device PB Digital Controller Single-use Video Pancreaticobiliary Scope Lockado(TM) Repositionable Hemostasis Clip CAPTurator Advanced Tissue Resection Device Single-Use Biopsy Forceps Precisor Disposable Biopsy Forceps (Transferred from CONMED CORPORATION) Jumbo Single-use Biopsy Forceps OptiBite Disposable Biopsy Forceps Pulmonary Hydro-Slide Guidewire Disposable Dual Action Tissue Closure Device Through the Scope Tracheal Stent System Disposable Distal Cap Tracheal Stent System (Y-Shaped) Disposable Cleaning Brush Disposable Dilator Brush Single-Use Video Bronchoscope Digital Controller LuminScanTM Imaging System Console-EOCT-C1-10-10-Disposable Imaging Kit-BOP-18-55-25-7 LuminScanTM Imaging System Console-EOCT-C1-10-10-Disposable Imaging Kit-BOP-16-30-25-7 LuminScanTM Imaging System Console-EOCT-C1-10-10-Disposable Imaging Kit-BOP-20-80-25-7 LuminScanTM Imaging System Console-EOCT-C1-10-10-Disposable Imaging Kit-BOP-20-55-25-7 LuminScanTM Imaging System Console-EOCT-C1-10-10-Disposable Imaging Kit-BOP-18-80-25-7 LuminScanTM Imaging System Console-EOCT-C1-10-10-Disposable Imaging Kit-BOP-20-30-25-7 LuminScanTM Imaging System Console-EOCT-C1-10-10-Disposable Imaging Kit-BOP-16-80-25-7 LuminScanTM Imaging System Console-EOCT-C1-10-10-Disposable Imaging Kit-BOP-16-55-25-7 LuminScanTM Imaging System Console-EOCT-C1-10-10-Disposable Imaging Kit-BOP-18-30-25-7 Retrieval Balloon / short-wire compatible Sterile Biliary Stone Retrieval Balloon Catheter Sterile Hydro-Slide Guidewire Single-Use Marked Spring Tip Guidewire SpiraTrax Sterile Hydro-Slide Guidewire BlueBoost(TM) Submucosal Injectable Solution Reliant(TM) Multistage Dilatation Balloon Catheter Grasping Forceps Spray Catheter Disposable Inflation Device Insuflator Pump

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PKL	Hemostatic Metal Clip For The Gi Tract	Gastroenterology, Urology	Class 2	876.4400	2024-03-20
ESW	Prosthesis, Esophageal	General, Plastic Surgery	Class 2	878.3610	2018-05-21
FDS	Gastroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2025-07-01
KTI	Bronchoscope Accessory	Ear, Nose, Throat	Class 2	874.4680	2022-07-20
GAE	Snare, Surgical	General, Plastic Surgery	Class 1	878.4800	2015-03-12
FED	Endoscopic Access Overtube, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2019-03-07
PKL	Hemostatic Metal Clip For The Gi Tract	Gastroenterology, Urology	Class 2	876.4400	2025-09-11
OCZ	Endoscopic Grasping/Cutting Instrument, Non-Powered	Gastroenterology, Urology	Class 2	876.1500	2016-03-02
FCG	Biopsy Needle	Gastroenterology, Urology	Class 2	876.1075	2021-12-07
ODG	Endoscopic Ultrasound System, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2021-12-07
KGE	Forceps, Biopsy, Electric	Gastroenterology, Urology	Class 2	876.4300	2021-03-16
FBK	Endoscopic Injection Needle, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2015-06-03
ODG	Endoscopic Ultrasound System, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2024-01-15
FHN	Ligator, Hemorrhoidal	Gastroenterology, Urology	Class 2	876.4400	2015-03-24
FBK	Endoscopic Injection Needle, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2026-06-02
KGE	Forceps, Biopsy, Electric	Gastroenterology, Urology	Class 2	876.4300	2021-03-16
MNK	Endoscopic Bite Block	Gastroenterology, Urology	Class 1	876.1500	2012-08-26
FGX	Snare, Non-Electrical	Gastroenterology, Urology	Class 1	876.4730	2013-03-24
FDI	Snare, Flexible	Gastroenterology, Urology	Class 2	876.4300	2015-07-31
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	Class 2	876.5010	2023-09-07
ODC	Endoscope Channel Accessory	Gastroenterology, Urology	Class 2	876.1500	2022-03-29
KDQ	Bottle, Collection, Vacuum	General Hospital	Class 2	880.6740	2013-04-03
FDX	Endoscopic Cytology Brush	Gastroenterology, Urology	Class 2	876.1500	2018-03-05
FBN	Choledochoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2026-04-06
FET	Endoscopic Video Imaging System/Component, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2026-04-06
PKL	Hemostatic Metal Clip For The Gi Tract	Gastroenterology, Urology	Class 2	876.4400	2018-12-18
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2017-10-24
PKL	Hemostatic Metal Clip For The Gi Tract	Gastroenterology, Urology	Class 2	876.4400	2018-06-06
FTY	Tape, Measuring, Rulers And Calipers	General, Plastic Surgery	Class 1	878.4800	2019-01-31
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2020-07-26
KNS	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	Gastroenterology, Urology	Class 2	876.4300	2020-07-26
FQH	Lavage, Jet	General Hospital	Class 2	880.5475	2021-12-19
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2021-12-19
PKL	Hemostatic Metal Clip For The Gi Tract	Gastroenterology, Urology	Class 2	876.4400	2022-06-15
PKL	Hemostatic Metal Clip For The Gi Tract	Gastroenterology, Urology	Class 2	876.4400	2017-01-08
FQH	Lavage, Jet	General Hospital	Class 2	880.5475	2025-02-05
NTN	Led Light Source	Gastroenterology, Urology	Class 2	876.1500	2023-02-19
KQM	Camera, Surgical And Accessories	General, Plastic Surgery	Class 1	878.4160	2023-02-19
FBN	Choledochoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2023-02-19
PKL	Hemostatic Metal Clip For The Gi Tract	Gastroenterology, Urology	Class 2	876.4400	2021-01-14
FDI	Snare, Flexible	Gastroenterology, Urology	Class 2	876.4300	2026-02-23
FCL	Forceps, Biopsy, Non-Electric	Gastroenterology, Urology	Class 1	876.1075	2004-10-25
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2026-01-13
PKL	Hemostatic Metal Clip For The Gi Tract	Gastroenterology, Urology	Class 2	876.4400	2022-01-20
JCT	Prosthesis, Tracheal, Expandable	General, Plastic Surgery	Class 2	878.3720	2022-07-08
FBN	Choledochoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2026-03-23
JCT	Prosthesis, Tracheal, Expandable	General, Plastic Surgery	Class 2	878.3720	2021-10-30
MNL	Accessories, Cleaning Brushes, For Endoscope	Gastroenterology, Urology	Class 1	876.1500	2011-09-07
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2022-07-08
NQQ	System, Imaging, Optical Coherence Tomography (Oct)	Radiology	Class 2	892.1560	2016-12-15
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	Class 2	876.5010	2022-05-06
OCY	Endoscopic Guidewire, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2019-02-15
PLL	Submucosal Injection Agent	Gastroenterology, Urology	Class 2	876.1500	2020-11-05
KNQ	Dilator, Esophageal	Gastroenterology, Urology	Class 2	876.5365	2018-10-22
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	Class 2	876.5010	2018-10-22
PTS	Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt	Gastroenterology, Urology	Class 2	876.1500	2022-07-06
GCE	Adaptor, Catheter	General, Plastic Surgery	Class 1	878.4200	2018-05-15
PTM	Syringe, Balloon Inflation, Exempt	Cardiovascular	Class 2	870.1650	2017-11-10

Official Correspondent

Sally He

US Agent Details

Chris Li Email: ra.mtus@mtmed.com Phone: (877) 5524027

Related Public Records

Same Entity

Micro-Tech (Nanjing) Co., Ltd.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3013440400	Micro-Tech (Nanjing) Co., Ltd.	Nanjing Jiangsu, CN

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K232314	FUJIFILM Healthcare Americas Corporation	Hood (DH-106STL, DH-116STL, DH-126STL, DH-096ST)	2023-09-01
K230752	FUJIFILM Healthcare Americas Corporation	Over-tube (TR-1208A); Over-tube (TR-1504A); Over-tube (TR-1507A)	2023-09-15
K923489	Cox Medical Ent., Inc.	COX DISPOSABLE RETRIEVAL DEVICES	1992-09-23
K150891	Covidien, LLC( Formerly Beacon Endoscopic Corp.)	BNX Fine Needle Aspiration System and SharkCore LG Fine Needle Biopsy System	2015-05-01
K000397	Boston Scientific Corp	SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODELS 4225, 4228; INJECTION SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODEL	2000-03-07

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0015-2023	Hobbs Medical, Inc.	2	Hobbs Medical Polypectomy Snare Catalog Number: 4563
Z-0016-2023	Hobbs Medical, Inc.	2	Hobbs Medical Polypectomy Snare Catalog Number: 4564
Z-0026-2023	Hobbs Medical, Inc.	2	Hobbs Helical Retrieval Basket Catalog Number: 4806
Z-0027-2023	Hobbs Medical, Inc.	2	Hobbs Helical Retrieval Basket Catalog Number: 4808
Z-0028-2023	Hobbs Medical, Inc.	2	Hobbs Helical Retrieval Basket Catalog Number: 4814

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004837686. Last updated year: 2026. Please use registration number 3004837686 when referencing this establishment in official correspondence.