Zhejiang Soudon Medical Technology Co.,Ltd
Hangzhou Zhejiang, CN
ZHEJIANG SOUDON MEDICAL TECHNOLOGY CO.,LTD appears in FDA device records in Hangzhou Zhejiang, CN. FDA records list 5 510(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 5 510(k) clearances for Zhejiang Soudon Medical Technology Co.,Ltd between 2023 and 2026. The busiest year on record is 2023, with 2. The most recent is 2026, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2023 | 2 |
| 2024 | 1 |
| 2026 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K253013 | Disposable Stone Retrieval Balloon Catheter | GCA | Substantially Equivalent | |
| K253056 | Disposable Stone Extraction Basket | LQR | Substantially Equivalent | |
| K232450 | Disposable Hemostatic Clips | PKL | Substantially Equivalent | |
| K232442 | Disposable Endoscope Injection Needles | FBK | Substantially Equivalent | |
| K232476 | Disposable Sphincterotome | KNS | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3025311469 | 3025311469 | ZHEJIANG SOUDON MEDICAL TECHNOLOGY CO.,LTD | Room 401, Building 1, No.99, Lvzhou Road, Hangzhou Zhejiang 311100 CN | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- MNLAccessories, Cleaning Brushes, For Endoscope
- GCABiliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection
- LQRDislodger, Stone, Biliary
- MNKEndoscopic Bite Block
- OCYEndoscopic Guidewire, Gastroenterology-Urology
- FBKEndoscopic Injection Needle, Gastroenterology-Urology
- FCLForceps, Biopsy, Non-Electric
- PKLHemostatic Metal Clip For The Gi Tract
- KNSUnit, Electrosurgical, Endoscopic (With Or Without Accessories)
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