Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010288205

FEI Number

3010288205

Entity Name

Hangzhou AGS MedTech Co., Ltd.

City/State/Country

Hangzhou Zhejiang, CN

Establishment Address

Building 2,5 and 7, No.389 Xingzhong Road, Linping District, Hangzhou Zhejiang 311103, CN

Establishment Type(s)

Repack or Relabel Medical Device,Manufacture Medical Device

Owner / Operator

Hangzhou AGS MedTech Co., Ltd. (Owner Number: 10052959)

Owner / Operator Contact Address

Building 2,5 and 7, No.389 Xingzhong Road, Linping District, Hangzhou, CN-ZJ 311103, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

AGS AGS AGS AGS AGS AGS AGS AGS AGS AGS AGS AGS AGS AGS / AGS

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GCA	Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection	Gastroenterology, Urology	Class 2	876.5010	2020-05-06
PKL	Hemostatic Metal Clip For The Gi Tract	Gastroenterology, Urology	Class 2	876.4400	2023-08-30
LQR	Dislodger, Stone, Biliary	Gastroenterology, Urology	Class 2	876.5010	2020-12-23
ODC	Endoscope Channel Accessory	Gastroenterology, Urology	Class 2	876.1500	2020-12-23
FDI	Snare, Flexible	Gastroenterology, Urology	Class 2	876.4300	2018-05-22
OCX	Endoscopic Irrigation/Suction System	Gastroenterology, Urology	Class 2	876.1500	2025-03-23
KNS	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	Gastroenterology, Urology	Class 2	876.4300	2023-05-10
KGE	Forceps, Biopsy, Electric	Gastroenterology, Urology	Class 2	876.4300	2021-10-21
KNS	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	Gastroenterology, Urology	Class 2	876.4300	2021-02-18
PKL	Hemostatic Metal Clip For The Gi Tract	Gastroenterology, Urology	Class 2	876.4400	2018-04-16
FDI	Snare, Flexible	Gastroenterology, Urology	Class 2	876.4300	2023-05-10
PKL	Hemostatic Metal Clip For The Gi Tract	Gastroenterology, Urology	Class 2	876.4400	2022-03-08
FDS	Gastroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2022-05-05
FDF	Colonoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2022-05-05
KNQ	Dilator, Esophageal	Gastroenterology, Urology	Class 2	876.5365	2022-05-05
FBK	Endoscopic Injection Needle, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2020-03-02
PTS	Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt	Gastroenterology, Urology	Class 2	876.1500	2018-07-02
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2020-05-27
FDI	Snare, Flexible	Gastroenterology, Urology	Class 2	876.4300	2020-05-27
KNS	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	Gastroenterology, Urology	Class 2	876.4300	2020-05-27
MNL	Accessories, Cleaning Brushes, For Endoscope	Gastroenterology, Urology	Class 1	876.1500	2020-08-05
OCY	Endoscopic Guidewire, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2018-12-19

Official Correspondent

Yanping Fu

US Agent Details

Hewu Ma Email: hewuma@hotmail.com Phone: (317) 4162074

Related Public Records

Same Entity

Hangzhou AGS MedTech 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
3035434483	AGS MEDTECH (THAILAND) CO., LTD.	Pluak Daeng District Rayong, TH

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K200745	United States Endoscopy Group, Inc.	Lariat, Hot/Cold Snare	2020-04-21
K172288	Wilson-Cook Medical Inc./Cook Endoscopy	Fusion OMNI Sphincterotome	2018-04-17
K232314	FUJIFILM Healthcare Americas Corporation	Hood (DH-106STL, DH-116STL, DH-126STL, DH-096ST)	2023-09-01
K990935	Pilling Weck Surgical	JACKSON ESOPHAGEAL DILATOR	1999-05-17
K970809	Somnus Medical Technologies, Inc.	BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL	1997-06-18

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2016	US Endoscopy Group Inc	2	Histolock Resection Device, US Endoscopy. An electrosurgical device designed to be used to endoscopically grasp, dissect and transect tissue during gastrointestinal endoscopic procedures.
Z-0010-2023	Hobbs Medical, Inc.	2	Hobbs Medical Spray Catheter: The Mistifier: 2.6mm 260cm Disposable For endoscopy procedures Ref: 2190
Z-0011-2023	Hobbs Medical, Inc.	2	Hobbs Medical Spray Catheter: The Mistifier: 2.6mm 165cm Disposable For endoscopy procedures Ref: 2191
Z-0020-2023	Hobbs Medical, Inc.	2	Hobbs Posi-Stop Injection Needle Catalog Number: 4702
Z-0021-2023	Hobbs Medical, Inc.	2	Hobbs Posi-Stop Injection Needle Catalog Number: 4704

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010288205. Last updated year: 2026. Please use registration number 3010288205 when referencing this establishment in official correspondence.