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Shenzhen HugeMed Medical Technical Development Co., Ltd.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 7
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
| K250695 | Single-use Ureteral Access Sheath | July 8, 2025 |
| K241444 | Biliary Pancreaticobiliary Scope System | January 21, 2025 |
| K240374 | Ureterorenoscope System | May 10, 2024 |
| K232435 | Rhinolaryngoscope system | April 26, 2024 |
| K231497 | Choledochoscope System | March 6, 2024 |
| K231118 | Cystoscope System | November 13, 2023 |
| K222910 | Bronchoscope System | April 11, 2023 |