Cleared Traditional

K081816 - VOCALIS AND VOCALIS SM (FDA 510(k) Clearance)

K081816 · Cytophil, Inc. · Ear, Nose, Throat device

Jan 2009

Decision

193d

Days

Class 2

Risk

K081816 is an FDA 510(k) clearance for the VOCALIS AND VOCALIS SM. This device is classified as a System, Vocal Cord Medialization (Class II - Special Controls, product code MIX).

Submitted by Cytophil, Inc. (Whitefish Bay, US). The FDA issued a Cleared decision on January 5, 2009, 193 days after receiving the submission on June 26, 2008.

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

Submission Details

510(k) Number	K081816 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 26, 2008
Decision Date	January 05, 2009
Days to Decision	193 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Summary PDF