Cleared Traditional

TIGR Matrix Surgical Mesh, TIGR Surgical Mesh

K191749 · Novus Scientific AB · General & Plastic Surgery

Mar 2020

Decision

269d

Days

Class 2

Risk

About This 510(k) Submission

K191749 is an FDA 510(k) clearance for the TIGR Matrix Surgical Mesh, TIGR Surgical Mesh, a Mesh, Surgical, Absorbable, Abdominal Hernia (Class II — Special Controls, product code OWT), submitted by Novus Scientific AB (Uppsala, SE). The FDA issued a Cleared decision on March 26, 2020, 269 days after receiving the submission on July 1, 2019. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.3300.

Submission Details

510(k) Number	K191749 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 01, 2019
Decision Date	March 26, 2020
Days to Decision	269 days
Submission Type	Traditional
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.