510(k) K230679

WellsForm Tricuspid Annuloplasty Band (WF) by Genesee Biomedical, Inc. — Product Code KRH

K230679 is an FDA 510(k) premarket notification submitted by Genesee Biomedical, Inc. for the device "WellsForm Tricuspid Annuloplasty Band (WF)". The FDA issued a decision of Substantially Equivalent on May 26, 2023. The device falls under product code KRH (Ring, Annuloplasty), a Class II device regulated under 21 CFR 870.3800. Genesee Biomedical, Inc. has at least 10 other 510(k) clearances on record.