Ultraviolet Light-Based Microbial Reduction Device For Luer-Activated Valves
SGX is the FDA product code for Ultraviolet Light-Based Microbial Reduction Device For Luer-Activated Valves, a class II device type, regulated under 21 CFR 880.6512. FDA's definition for this code reads: "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...". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.
Classification record
- Product code
- SGX
- Device name
- Ultraviolet Light-Based Microbial Reduction Device For Luer-Activated Valves
- FDA 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.
- Regulation
- 21 CFR 880.6512
- Device class
- Class II
- Review panel
- General Hospital
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 1
- Ingested recalls
- 0
Clearances, product code SGX
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2025 | 1 |
Applicants with the most clearances
Product code SGX| Applicant | Clearances |
|---|---|
| Hai Solutions Inc | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
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