Cleared Special

K080956 - MODIFICATION TO VF GEL PLUS (FDA 510(k) Clearance)

K080956 · Coapt Systems, Inc. · Ear, Nose, Throat device

Apr 2008

Decision

22d

Days

Class 2

Risk

K080956 is an FDA 510(k) clearance for the MODIFICATION TO 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 April 25, 2008, 22 days after receiving the submission on April 3, 2008.

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

Submission Details

510(k) Number	K080956 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	April 03, 2008
Decision Date	April 25, 2008
Days to Decision	22 days
Submission Type	Special
Review Panel	Ear, Nose, Throat (EN)
Summary	Summary PDF