Cleared Traditional

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 · Caldera Medical, Inc. · Gastroenterology & Urology

May 2018

Decision

246d

Days

Class 2

Risk

About This 510(k) Submission

K172614 is an FDA 510(k) clearance for the 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 Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence (Class II — Special Controls, product code PWJ), submitted by Caldera Medical, Inc. (Agoura Hills, US). The FDA issued a Cleared decision on May 4, 2018, 246 days after receiving the submission on August 31, 2017. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 884.4910.

Submission Details

510(k) Number	K172614 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 31, 2017
Decision Date	May 04, 2018
Days to Decision	246 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	Statement

Device Classification

Product Code	PWJ — Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 884.4910
Definition	Used To Aid In Insertion, Placement, Fixation, Or Anchoring Of Surgical Mesh For Stress Urinary Incontinence