Cleared Special

GORE SEAMGUARD Reinforcement

K150551 · W.L. Gore & Associates, Inc. · General & Plastic Surgery

Mar 2015

Decision

26d

Days

Class 2

Risk

About This 510(k) Submission

K150551 is an FDA 510(k) clearance for the GORE SEAMGUARD Reinforcement, a Mesh, Surgical, Absorbable, Staple Line Reinforcement (Class II — Special Controls, product code OXC), submitted by W.L. Gore & Associates, Inc. (Phoenix, US). The FDA issued a Cleared decision on March 30, 2015, 26 days after receiving the submission on March 4, 2015. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.3300.

Submission Details

510(k) Number	K150551 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 04, 2015
Decision Date	March 30, 2015
Days to Decision	26 days
Submission Type	Special
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF

Device Classification

Product Code	OXC — Mesh, Surgical, Absorbable, Staple Line Reinforcement
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 878.3300
Definition	For Reinforcement Of Soft Tissue Where Weakness Exists During Staple Line Reinforcement Procedures.