ClearanceBrief
Company ยท CN

Alton (Shanghai) Medical Instruments Co., Ltd.

FDA 510(k) clearances and medical device recalls filed under this name, 2023 to 2025. Name variants (Inc, Corp, punctuation) are merged.

6510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)

Product codes

CodeDeviceRecords
FADStent, Ureteral1
FBKEndoscopic Injection Needle, Gastroenterology-Urology1
FDSGastroscope And Accessories, Flexible/Rigid1
KTIBronchoscope Accessory1
ODCEndoscope Channel Accessory1
PKLHemostatic Metal Clip For The Gi Tract1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Jun 18, 2025K243039Ureteral Stents (AF-D series)
Alton (Shanghai) Medical Instruments Co., Ltd., CN
FAD
May 30, 2025K242635Endoscopic Distal Attachment (AF-D series)
Alton (Shanghai) Medical Instruments Co., Ltd., CN
FDS
Mar 4, 2025K241679Disposable Cytology Brush (AF series)
Alton (Shanghai) Medical Instruments Co., Ltd., CN
KTI
Oct 1, 2024K241285Disposable Endoscope Valves Set (AF series)
Alton (Shanghai) Medical Instruments Co., Ltd., CN
ODC
Jan 11, 2024K231633Disposable Hemoclip (AF series)
Alton (Shanghai) Medical Instruments Co., Ltd., CN
PKL
Sep 27, 2023K230925Disposable Injection Needle AF series
Alton (Shanghai) Medical Instruments Co., Ltd., CN
FBK

Latest recalls

DateFirm and productCodeLinked 510(k)
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