510(k) K243431

Medicom Sterilization Pouch and Reel by Medicom Asia-Pacific Holdings Ltd. Taiwan Branch. — Product Code FRG

K243431 is an FDA 510(k) premarket notification submitted by Medicom Asia-Pacific Holdings Ltd. Taiwan Branch. for the device "Medicom Sterilization Pouch and Reel". The FDA issued a decision of Substantially Equivalent on February 21, 2025. The device falls under product code FRG (Wrap, Sterilization), a Class II device regulated under 21 CFR 880.6850.