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

K172614 is the FDA 510(k) clearance record for 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, a class II device, cleared for Caldera Medical, Inc. on 2018-05-04 under FDA product code PWJ (Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence). FDA's definition for product code PWJ reads: "Used to aid in insertion, placement, fixation, or anchoring of surgical mesh for stress urinary incontinence". FDA records list 24 510(k) clearances for Caldera Medical, Inc., from 2006-02-22 to 2023-11-30. As of 2026-09-10, FDA records show no recalls naming K172614.