Cleared Special

EIGR SURGICAL ILLUMINATION SYSTEM

K113697 · Invuity, Inc. · General & Plastic Surgery

Feb 2012

Decision

56d

Days

Class 2

Risk

About This 510(k) Submission

K113697 is an FDA 510(k) clearance for the EIGR SURGICAL ILLUMINATION SYSTEM, a Light, Surgical, Fiberoptic (Class II — Special Controls, product code FST), submitted by Invuity, Inc. (San Franciso, US). The FDA issued a Cleared decision on February 10, 2012, 56 days after receiving the submission on December 16, 2011. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4580.

Submission Details

510(k) Number	K113697 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 16, 2011
Decision Date	February 10, 2012
Days to Decision	56 days
Submission Type	Special
Review Panel	General & Plastic Surgery (SU)
Summary	Statement