Changzhou, CN · 7 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| KNS | Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | Class II | Gastroenterology, Urology | 1 | 2024-03-29 |
| GCA | Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection | Class II | Gastroenterology, Urology | 1 | 2024-02-26 |
| FGE | Stents, Drains And Dilators For The Biliary Ducts | Class II | Gastroenterology, Urology | 1 | 2024-02-15 |
| LQR | Dislodger, Stone, Biliary | Class II | Gastroenterology, Urology | 1 | 2023-09-12 |
| PKL | Hemostatic Metal Clip For The Gi Tract | Class II | Gastroenterology, Urology | 1 | 2023-03-28 |
| FDI | Snare, Flexible | Class II | Gastroenterology, Urology | 1 | 2022-09-22 |
| FBK | Endoscopic Injection Needle, Gastroenterology-Urology | Class II | Gastroenterology, Urology | 1 | 2022-07-29 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2024-03-29 | K232825 | Disposable Sphincterotome | KNS | Class II | Gastroenterology, Urology |
| 2024-02-26 | K232752 | Stone Extraction Balloon (VDK-BAL-23-11/13/15-B,VDK-BAL-23-15/18/20-B,VDK-BAL-23-9/12/15-B,VDK-BAL-23-10/13/16-B,VDK-BAL-23-8.5/11.5/15-B,VDK-BAL-23-12/15/18-B,VDK-BAL-23-11/13/15-C,VDK-BAL-23-15/18/20-C,VDK-BAL-23-9/12/15-C,VDK-BAL-23-10/13/16-C,VDK-BAL-23-8.5/11.5/15-C,VDK-BAL-23-12/15/18-C) | GCA | Class II | Gastroenterology, Urology |
| 2024-02-15 | K232245 | VedDilator ^TM (3-Stage Balloon Dilation Catheter) | FGE | Class II | Gastroenterology, Urology |
| 2023-09-12 | K230598 | Stone Extraction Baskets | LQR | Class II | Gastroenterology, Urology |
| 2023-03-28 | K222146 | Disposable Endoscopic Hemoclip | PKL | Class II | Gastroenterology, Urology |
| 2022-09-22 | K220089 | Disposable Polyp Snare | FDI | Class II | Gastroenterology, Urology |
| 2022-07-29 | K213914 | Injection Needle | FBK | Class II | Gastroenterology, Urology |