Tianchang, CN · 11 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| FMF | — | — | — | 3 | 2022-07-14 |
| PIF | Gastrointestinal Tubes With Enteral Specific Connectors | Class II | Gastroenterology, Urology | 1 | 2023-08-17 |
| PNR | Enteral Syringes With Enteral Specific Connectors | Class II | Gastroenterology, Urology | 1 | 2023-08-17 |
| NGT | Saline, Vascular Access Flush | Class II | General Hospital | 1 | 2023-08-12 |
| SCL | Allergen And Vaccine Delivery Needles | Class II | General Hospital | 1 | 2022-12-06 |
| FXX | — | — | — | 1 | 2021-10-24 |
| MEG | Syringe, Antistick | Class II | General Hospital | 1 | 2020-09-11 |
| FPA | — | — | — | 1 | 2020-08-26 |
| FMI | Needle, Hypodermic, Single Lumen | Class II | General Hospital | 1 | 2020-08-06 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2023-08-17 | K222773 | Feeding Tube | PIF | Class II | Gastroenterology, Urology |
| 2023-08-17 | K222772 | Oral/Enteral Syringe with ENFit connector | PNR | Class II | Gastroenterology, Urology |
| 2023-08-12 | K230756 | TK Pre-Filled Normal Saline Flush Syringe | NGT | Class II | General Hospital |
| 2022-12-06 | K222385 | Bifurcated Needle | SCL | Class II | General Hospital |
| 2022-07-14 | K220204 | Disposabel Syringe with permanently attached needle, Safety Syringe with permanently attached needle | FMF | — | — |
| 2021-10-24 | K212368 | Surgical Face Mask | FXX | — | — |
| 2021-08-24 | K210464 | Auto Disable Syringe | FMF | — | — |
| 2020-09-11 | K191639 | TK Insulin Syringe with/without Saftey Retractable Device | MEG | Class II | General Hospital |
| 2020-08-26 | K191640 | TK Intravascular Administration Set | FPA | — | — |
| 2020-08-06 | K191644 | TK Safety Needle | FMI | Class II | General Hospital |
| 2020-01-06 | K191642 | TK Sterile Piston Syringe without Needle | FMF | — | — |