Cleared Special

K121274 - PIXEL APP (FDA 510(k) Clearance)

Class I General & Plastic Surgery device.

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

K121274 is an FDA 510(k) clearance for the PIXEL APP. Classified as Counter, Sponge, Surgical (product code LWH), Class I - General Controls.

Submitted by Gauss Surgical, Inc., (Cupertino, US). The FDA issued a Cleared decision on June 27, 2012 after a review of 61 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 880.2740 - the FDA general and plastic surgery device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Gauss Surgical, Inc., devices

Submission Details

510(k) Number K121274 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 114d · This submission: 61d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code LWH Counter, Sponge, Surgical
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.2740
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.