Cleared Traditional

K193144 - T-Line Hernia Mesh (FDA 510(k) Clearance)

K193144 · Deep Blue Medical Advances, Inc. · General & Plastic Surgery device

Mar 2020

Decision

138d

Days

Class 2

Risk

K193144 is an FDA 510(k) clearance for the T-Line Hernia Mesh. This device is classified as a Mesh, Surgical, Polymeric (Class II - Special Controls, product code FTL).

Submitted by Deep Blue Medical Advances, Inc. (Durham, US). The FDA issued a Cleared decision on March 30, 2020, 138 days after receiving the submission on November 13, 2019.

This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.3300.

Submission Details

510(k) Number	K193144 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 13, 2019
Decision Date	March 30, 2020
Days to Decision	138 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF