Alton Shanghai Medical Instruments Co Ltd
Shanghai, CN
ALTON SHANGHAI MEDICAL INSTRUMENTS CO LTD appears in FDA device records in Shanghai, CN. FDA records list 6 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 6 510(k) clearances for Alton Shanghai Medical Instruments Co Ltd between 2023 and 2025. The busiest year on record is 2025, with 3. The most recent is 2025, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2023 | 1 |
| 2024 | 2 |
| 2025 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K243039 | Ureteral Stents (AF-D series) | FAD | Substantially Equivalent | |
| K242635 | Endoscopic Distal Attachment (AF-D series) | FDS | Substantially Equivalent | |
| K241679 | Disposable Cytology Brush (AF series) | KTI | Substantially Equivalent | |
| K241285 | Disposable Endoscope Valves Set (AF series) | ODC | Substantially Equivalent | |
| K231633 | Disposable Hemoclip (AF series) | PKL | Substantially Equivalent | |
| K230925 | Disposable Injection Needle AF series | FBK | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3008797804 | 3008797804 | ALTON SHANGHAI MEDICAL INSTRUMENTS CO LTD | No.24 Building Jinshao Rd.1688.Baoshan District, Shanghai 200949 CN | 2026 | and 10 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- MNLAccessories, Cleaning Brushes, For Endoscope
- FEAAttachment, Teaching, For Endoscope
- PTTBiliary Catheter For Irrigation And Contrast Injection, Exempt
- KDQBottle, Collection, Vacuum
- KTIBronchoscope Accessory
- FDFColonoscope And Accessories, Flexible/Rigid
- FDYDevice, Measuring, For Panendoscope
- ODCEndoscope Channel Accessory
- MNKEndoscopic Bite Block
- FDXEndoscopic Cytology Brush
- PTSEndoscopic Grasping/Cutting Instrument, Non-Powered, Exempt
- OCYEndoscopic Guidewire, Gastroenterology-Urology
- FBKEndoscopic Injection Needle, Gastroenterology-Urology
- FCLForceps, Biopsy, Non-Electric
- FDSGastroscope And Accessories, Flexible/Rigid
- PKLHemostatic Metal Clip For The Gi Tract
- MNDLigator, Esophageal
- FHNLigator, Hemorrhoidal
- FGXSnare, Non-Electrical
- FADStent, Ureteral
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain