Cleared Special

K121274 - PIXEL APP

K121274 is an FDA 510(k) clearance for PIXEL APP, manufactured by Gauss Surgical, Inc.,. The device is a Class 1 General & Plastic Surgery device with product code LWH cleared through the Special 510(k) pathway after a 61-day FDA review.

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.

FDA 510(k) Submission Details - K121274

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
54d faster than avg
Panel avg: 115d · This submission: 61d
Pathway characteristics
Modification to existing cleared device.

LWH Device Classification - Class 1, General Controls

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.

Regulatory Peers - LWH Counter, Sponge, Surgical

All 14
Devices cleared under the same product code (LWH) and FDA review panel - the closest regulatory comparables to K121274.
PIXEL APP
K120473 · Gauss Surgical, Inc., · Apr 2012
ORLOCATE SYSTEM MODEL ORL 100
K100551 · Haldor Advanced Technologies, Ltd. · Aug 2010
SMARTWAND-DTX
K093557 · Clearcount Medical Solutions · Dec 2009
SMARTSPONGE PLUS SYSTEM
K073180 · Clearcount Medical Solutions, Inc. · Nov 2007
SMARTSPONGE SYSTEM
K071355 · Clearcount Medical Solutions, Inc. · May 2007
MEDLINE SURGICAL SPONGE SCANNER
K061316 · Medline Industries, Inc. · Nov 2006
K121274 · PIXEL APP
Download PDF Gauss Surgical, Inc.,