Cleared Special

K051190 - XENFORM SOFT TISSUE REPAIR MATRIX
(FDA 510(k) Clearance)

K051190 · Tei Biosciences, Inc. · Obstetrics & Gynecology
Jun 2005
Decision
31d
Days
Class 2
Risk

K051190 is an FDA 510(k) clearance for the XENFORM SOFT TISSUE REPAIR MATRIX. This device is classified as a Mesh, Surgical, Non-synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed (Class II — Special Controls, product code PAJ).

Submitted by Tei Biosciences, Inc. (Boston, US). The FDA issued a Cleared decision on June 10, 2005, 31 days after receiving the submission on May 10, 2005.

This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 878.3300. Bridging Material To Attach The Vaginal Apex Or Uterus To The Sacral Promontory; Procedures Include Abdominal Sacrocolpopexy, Laparoscopic Sacrocolpopexy And Robot-assisted Sacrocolpopexy..

Submission Details

510(k) Number K051190 FDA.gov
FDA Decision Cleared SESE
Date Received May 10, 2005
Decision Date June 10, 2005
Days to Decision 31 days
Submission Type Special
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF

Device Classification

Product Code PAJ — Mesh, Surgical, Non-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 Or Uterus To The Sacral Promontory; Procedures Include Abdominal Sacrocolpopexy, Laparoscopic Sacrocolpopexy And Robot-assisted Sacrocolpopexy.