510(k) K233477

Cryo-straw (Type I, Type III); Warming Kit (A-4ML, B-8ML); Vitrification Kit (A-3ML, B-6ML) by Shandong Wego Ruisheng Medical Device Co., Ltd. — Product Code MQL

K233477 is an FDA 510(k) premarket notification submitted by Shandong Wego Ruisheng Medical Device Co., Ltd. for the device "Cryo-straw (Type I, Type III); Warming Kit (A-4ML, B-8ML); Vitrification Kit (A-3ML, B-6ML)". The FDA issued a decision of Substantially Equivalent on July 1, 2024. The device falls under product code MQL (Media, Reproductive), a Class II device regulated under 21 CFR 884.6180.