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Ags Medtech (thailand) Co., Ltd.: FDA-registered device maker in Pluak Daeng District Rayong, Thailand, 5 510(k) clearances

Name: Ags Medtech (thailand) Co., Ltd. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Ags Medtech (thailand) Co., Ltd. is registered with the FDA (registration 3035434483) in Pluak Daeng District Rayong, Thailand. It lists 8 device types. The FDA files 5 510(k) clearances under its listings, the newest dated November 12, 2025. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3035434483
Address: 2F,7/ 582 moo 6,Map Yang Phon, Pluak Daeng District, Rayong, Thailand 21140, Pluak Daeng District Rayong, Thailand, 21140
Owner or operator: Hangzhou AGS MedTech Co., Ltd. (10052959)
Roles: Manufacturer, Repackager or relabeler
First device listed: October 29, 2016
Registered through: 2026
Brand names listed: AGS

Devices it lists

Device	Product code	Class	Role	Source
Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt	PTS	2	Manufacturer	accessdata.fda.gov
Endoscopic Guidewire, Gastroenterology-Urology	OCY	2	Manufacturer	accessdata.fda.gov
Endoscopic Injection Needle, Gastroenterology-Urology	FBK	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Forceps, Biopsy, Non-Electric	FCL	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Hemostatic Metal Clip For The Gi Tract	PKL	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Snare, Flexible	FDI	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Snare, Non-Electrical	FGX	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	KNS	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
November 12, 2025	K252271	Hemoclip	PKL	Substantially Equivalent	Hangzhou AGS MedTech Co., Ltd.	accessdata.fda.gov
May 3, 2023	K222421	Sphincterotome	KNS	Substantially Equivalent	Hangzhou AGS MedTech Co., Ltd.	accessdata.fda.gov
March 3, 2023	K221713	Polypectomy Snare	FDI	Substantially Equivalent	Hangzhou AGS MedTech Co., Ltd.	accessdata.fda.gov
March 3, 2022	K211787	Hemoclip	PKL	Substantially Equivalent	Hangzhou AGS MedTech Co., Ltd.	accessdata.fda.gov
February 27, 2020	K190032	Disposable Sclerotherapy Needle	FBK	Substantially Equivalent	Hangzhou AGS MedTech Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated November 12, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.