510(k) K223052

Peri-Guard and Supple Peri-Guard by Synovis Life Technologies, Inc. — Product Code FTM

K223052 is an FDA 510(k) premarket notification submitted by Synovis Life Technologies, Inc. for the device "Peri-Guard and Supple Peri-Guard". The FDA issued a decision of Substantially Equivalent on April 7, 2023. The device falls under product code FTM (Mesh, Surgical), a Class II device regulated under 21 CFR 878.3300. Synovis Life Technologies, Inc. has at least 8 other 510(k) clearances on record.