Cleared Traditional

K073164 - IVS TUNNELLER DEVICES (FDA 510(k) Clearance)

K073164 · Covidien UK Manufacturing, Ltd. · General & Plastic Surgery device

Mar 2008

Decision

117d

Days

Class 2

Risk

K073164 is an FDA 510(k) clearance for the IVS TUNNELLER DEVICES. This device is classified as a Mesh, Surgical, Polymeric (Class II - Special Controls, product code FTL).

Submitted by Covidien UK Manufacturing, Ltd. (North Haven, US). The FDA issued a Cleared decision on March 5, 2008, 117 days after receiving the submission on November 9, 2007.

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

Submission Details

510(k) Number	K073164 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 09, 2007
Decision Date	March 05, 2008
Days to Decision	117 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF