SGX — Ultraviolet Light-Based Microbial Reduction Device For Luer-Activated Valves Class II
FDA product code SGX covers "Ultraviolet Light-Based Microbial Reduction Device For Luer-Activated Valves", a Class II medical device regulated under 21 CFR 880.6512. Submissions are reviewed by the General Hospital panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- SGX
- Device Class
- Class II
- Regulation Number
- 880.6512
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General Hospital
- Implant
- No
Definition
An ultraviolet light-based microbial reduction device for luer-activated valves is a device that uses ultraviolet light to irradiate luer-activated valves (e.g., as used for intravascular administration). The device is intended to supplement the manual, physical microbicidal treatment of luer-activated valves by providing limited microbial reduction, and is not intended to disinfect or replace manual microbicidal treatment.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN250004 | Hai Solutions | QIKCAP System | Dec 23, 2025 |