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Alton Shanghai Medical Instruments Co Ltd: FDA-registered device maker in Shanghai, China, 6 510(k) clearances

Name: Alton Shanghai Medical Instruments Co Ltd FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Alton Shanghai Medical Instruments Co Ltd is registered with the FDA (registration 3008797804) in Shanghai, China. It lists 20 device types. The FDA files 6 510(k) clearances under its listings, the newest dated June 18, 2025. Registered through 2026. FDA data exported November 3, 2026.

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Get makers like this one Watch Alton Shanghai Medical Instruments Co Ltd

FDA registration number: 3008797804
Address: No.24 Building Jinshao Rd.1688.Baoshan District, Shanghai, China, 200949
Owner or operator: ALTON shanghai medical Instruments Co Ltd (10034985)
Roles: Complaint file establishment, Manufacturer
First device listed: January 23, 2011
Registered through: 2026
Brand names listed: Biliary Plastic Stent, Bite Blocks, Disposable Biopsy Forceps, Disposable Cleaning Brush, Disposable Cytology Brush (AF series), Disposable Drainage Collection device, Disposable Grasping Forceps, Disposable Guidewire and more

Devices it lists

Device	Product code	Class	Role	Source
Accessories, Cleaning Brushes, For Endoscope	MNL	1	Manufacturer	accessdata.fda.gov
Attachment, Teaching, For Endoscope	FEA	1	Manufacturer	accessdata.fda.gov
Biliary Catheter For Irrigation And Contrast Injection, Exempt	PTT	2	Manufacturer	accessdata.fda.gov
Bottle, Collection, Vacuum	KDQ	2	Manufacturer	accessdata.fda.gov
Bronchoscope Accessory	KTI	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Colonoscope And Accessories, Flexible/Rigid	FDF	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Device, Measuring, For Panendoscope	FDY	1	Manufacturer	accessdata.fda.gov
Endoscope Channel Accessory	ODC	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Endoscopic Bite Block	MNK	1	Manufacturer	accessdata.fda.gov
Endoscopic Cytology Brush	FDX	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
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	accessdata.fda.gov
Forceps, Biopsy, Non-Electric	FCL	1	Manufacturer	accessdata.fda.gov
Gastroscope And Accessories, Flexible/Rigid	FDS	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Hemostatic Metal Clip For The Gi Tract	PKL	2	Manufacturer	accessdata.fda.gov
Ligator, Esophageal	MND	2	Manufacturer	accessdata.fda.gov
Ligator, Hemorrhoidal	FHN	2	Manufacturer	accessdata.fda.gov
Snare, Non-Electrical	FGX	1	Manufacturer	accessdata.fda.gov
Stent, Ureteral	FAD	2	Complaint file establishment, 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
June 18, 2025	K243039	Ureteral Stents (AF-D series)	FAD	Substantially Equivalent	Alton (Shanghai) Medical Instruments Co., Ltd.	accessdata.fda.gov
May 30, 2025	K242635	Endoscopic Distal Attachment (AF-D series)	FDS	Substantially Equivalent	Alton (Shanghai) Medical Instruments Co., Ltd.	accessdata.fda.gov
March 4, 2025	K241679	Disposable Cytology Brush (AF series)	KTI	Substantially Equivalent	Alton (Shanghai) Medical Instruments Co., Ltd.	accessdata.fda.gov
October 1, 2024	K241285	Disposable Endoscope Valves Set (AF series)	ODC	Substantially Equivalent	Alton (Shanghai) Medical Instruments Co., Ltd.	accessdata.fda.gov
January 11, 2024	K231633	Disposable Hemoclip (AF series)	PKL	Substantially Equivalent	Alton (Shanghai) Medical Instruments Co., Ltd.	accessdata.fda.gov
September 27, 2023	K230925	Disposable Injection Needle AF series	FBK	Substantially Equivalent	Alton (Shanghai) Medical Instruments Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated June 18, 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.