Cleared Traditional

K120473 - PIXEL APP (FDA 510(k) Clearance)

Class I General & Plastic Surgery device.

K120473 · Gauss Surgical, Inc., · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2012
Decision
53d
Days
Class 1
Risk

K120473 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 April 9, 2012 after a review of 53 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Gauss Surgical, Inc., devices

Submission Details

510(k) Number K120473 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 16, 2012
Decision Date April 09, 2012
Days to Decision 53 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 114d · This submission: 53d
Pathway characteristics
Predicate-based equivalence.

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.