Guangzhou, CN · 7 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| GBM | Catheter, Urethral | Class II | Gastroenterology, Urology | 1 | 2025-03-05 |
| EZD | Catheter, Straight | Class II | Gastroenterology, Urology | 1 | 2023-05-22 |
| KOD | Catheter, Urological | Class II | Gastroenterology, Urology | 1 | 2022-12-16 |
| BTR | Tube, Tracheal (W/Wo Connector) | Class II | Anesthesiology | 1 | 2022-07-21 |
| ODC | Endoscope Channel Accessory | Class II | Gastroenterology, Urology | 1 | 2022-01-14 |
| EZL | Catheter, Retention Type, Balloon | Class II | Gastroenterology, Urology | 1 | 2021-04-08 |
| FED | Endoscopic Access Overtube, Gastroenterology-Urology | Class II | Gastroenterology, Urology | 1 | 2020-12-09 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2025-03-05 | K241734 | Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic Intermittent Catheter Compact | GBM | Class II | Gastroenterology, Urology |
| 2023-05-22 | K220722 | PVC Hydrophilic Urethral Catheter | EZD | Class II | Gastroenterology, Urology |
| 2022-12-16 | K220036 | Wellead Ureteral Catheter | KOD | Class II | Gastroenterology, Urology |
| 2022-07-21 | K211543 | Wei Nasal Jet Tube | BTR | Class II | Anesthesiology |
| 2022-01-14 | K211814 | Wellead Endoscopic Seal | ODC | Class II | Gastroenterology, Urology |
| 2021-04-08 | K202134 | Well Lead All Silicone Foley Catheter with Temperature Sensor | EZL | Class II | Gastroenterology, Urology |
| 2020-12-09 | K203119 | ClearPetra Suction-Evacuation Sheath | FED | Class II | Gastroenterology, Urology |