Cleared Special

GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement

K181940 · W.L. Gore & Associates, Inc. · General & Plastic Surgery

Aug 2018

Decision

29d

Days

Class 2

Risk

About This 510(k) Submission

K181940 is an FDA 510(k) clearance for the GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement, a Mesh, Surgical, Absorbable, Staple Line Reinforcement (Class II — Special Controls, product code OXC), submitted by W.L. Gore & Associates, Inc. (Elkton, US). The FDA issued a Cleared decision on August 17, 2018, 29 days after receiving the submission on July 19, 2018. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.3300.

Submission Details

510(k) Number	K181940 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 19, 2018
Decision Date	August 17, 2018
Days to Decision	29 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.