Cleared Traditional

Vertessa Lite

K150016 · Caldera Medical, Inc. · Obstetrics & Gynecology

Apr 2015

Decision

91d

Days

Class 2

Risk

About This 510(k) Submission

K150016 is an FDA 510(k) clearance for the Vertessa Lite, a Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed (Class II — Special Controls, product code OTO), submitted by Caldera Medical, Inc. (Agoura Hills, US). The FDA issued a Cleared decision on April 6, 2015, 91 days after receiving the submission on January 5, 2015. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 878.3300.

Submission Details

510(k) Number	K150016 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 05, 2015
Decision Date	April 06, 2015
Days to Decision	91 days
Submission Type	Traditional
Review Panel	Obstetrics & Gynecology (OB)
Summary	Summary PDF

Device Classification

Product Code	OTO — Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 878.3300
Definition	Bridging Material To Attach The Vaginal Apex To The Anterior Longitudinal Ligament Of The Sacrum; Procedures Include Abdominal Sacrocolpopexy And Laparoscopic Sacrocolpopexy.