Cleared Traditional

K071663 - VF GEL PLUS (FDA 510(k) Clearance)

K071663 · Coapt Systems, Inc. · Ear, Nose, Throat device

Feb 2008

Decision

242d

Days

Class 2

Risk

K071663 is an FDA 510(k) clearance for the VF GEL PLUS. This device is classified as a System, Vocal Cord Medialization (Class II - Special Controls, product code MIX).

Submitted by Coapt Systems, Inc. (Palo Alto, US). The FDA issued a Cleared decision on February 15, 2008, 242 days after receiving the submission on June 18, 2007.

This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.3620.

Submission Details

510(k) Number	K071663 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 18, 2007
Decision Date	February 15, 2008
Days to Decision	242 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Summary PDF