Cleared Special

GORE BIO-A Tissue Reinforcement

K191773 · W.L. Gore & Associates, Inc. · General & Plastic Surgery

Jul 2019

Decision

29d

Days

Class 2

Risk

About This 510(k) Submission

K191773 is an FDA 510(k) clearance for the GORE BIO-A Tissue Reinforcement, a Mesh, Surgical, Absorbable, Abdominal Hernia (Class II — Special Controls, product code OWT), submitted by W.L. Gore & Associates, Inc. (Elkton, US). The FDA issued a Cleared decision on July 31, 2019, 29 days after receiving the submission on July 2, 2019. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.3300.

Submission Details

510(k) Number	K191773 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 02, 2019
Decision Date	July 31, 2019
Days to Decision	29 days
Submission Type	Special
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF

Device Classification

Product Code	OWT — Mesh, Surgical, Absorbable, Abdominal Hernia
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 878.3300
Definition	For Reinforcement Of Soft Tissue Where Weakness Exists During Hernia Repair.