510(k) K172614

Caldera Medical Transobturator Helical Introducer, Left; Caldera Medical Transobturator Helical Introducer, Right; Caldera Medical Transobturator Large Helical Introducer, Left; Caldera Medical Transobturator Large Helical Introducer, Right; Caldera Medical Transobturator Inside-Out Introducer, Left by Caldera Medical, Inc. — Product Code PWJ

K172614 is an FDA 510(k) premarket notification submitted by Caldera Medical, Inc. for the device "Caldera Medical Transobturator Helical Introducer, Left; Caldera Medical Transobturator Helical Introducer, Right; Caldera Medical Transobturator Large Helical Introducer, Left; Caldera Medical Transobturator Large Helical Introducer, Right; Caldera Medical Transobturator Inside-Out Introducer, Left". The FDA issued a decision of Substantially Equivalent on May 4, 2018. The device falls under product code PWJ (Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence), a Class II device regulated under 21 CFR 884.4910. Caldera Medical, Inc. has at least 10 other 510(k) clearances on record.