Product code SGX— General Hospital
QIKCAP System
- Classification name
- Ultraviolet Light-Based Microbial Reduction Device For Luer-Activated Valves
- Device class
- Class 2
- Regulation
- 21 CFR 880.6512
- Advisory panel
- General Hospital
- Total cleared
- 1
- First cleared
- Most recent
FDA classification 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.”
Market context for product code SGX
FDA has cleared device under product code SGX, all in 2025, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Top applicants under product code SGX
Recent clearances under product code SGX
Data sourced from openFDA. This site is unofficial and independent of the FDA.