FDA product code SGX: 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. It is a Class II device, regulated under 21 CFR 880.6512 and reviewed by the General Hospital panel. Devices under SGX reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.

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.

Classification

Recalls for SGX devices

openFDA lists no recalls for product code SGX.

Frequently asked questions

What is FDA product code SGX?

SGX is the FDA product code for ultraviolet light-based microbial reduction device for luer-activated valves. It is a Class II device, regulated under 21 CFR 880.6512 and reviewed by the General Hospital panel.

What device class is SGX?

Class II, regulation 21 CFR 880.6512. Typical premarket route: 510(k).

Next steps

• Run an FDA pathway report with predicate devices for product code SGX
• Run a recall and safety report across every SGX manufacturer
• Watch product code SGX for new clearances and recalls

Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.

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