Cleared Special

PIXEL APP

K121274 · Gauss Surgical, Inc., · General & Plastic Surgery
Jun 2012
Decision
61d
Days
Class 1
Risk

About This 510(k) Submission

K121274 is an FDA 510(k) clearance for the PIXEL APP, a Counter, Sponge, Surgical (Class I — General Controls, product code LWH), submitted by Gauss Surgical, Inc., (Cupertino, US). The FDA issued a Cleared decision on June 27, 2012, 61 days after receiving the submission on April 27, 2012. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 880.2740.

Submission Details

510(k) Number K121274 FDA.gov
FDA Decision Cleared SESE
Date Received April 27, 2012
Decision Date June 27, 2012
Days to Decision 61 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Statement

Device Classification

Product Code LWH — Counter, Sponge, Surgical
Device Class Class I — General Controls
CFR Regulation 21 CFR 880.2740

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