510(k) K231641

Rotium Bioresorbable Wick by Nanofiber Solutions, LLC — Product Code MAI

K231641 is an FDA 510(k) premarket notification submitted by Nanofiber Solutions, LLC for the device "Rotium Bioresorbable Wick". The FDA issued a decision of Substantially Equivalent on July 5, 2023. The device falls under product code MAI (Fastener, Fixation, Biodegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3030. Nanofiber Solutions, LLC has at least 5 other 510(k) clearances on record.