Cleared Special

K113697 - EIGR SURGICAL ILLUMINATION SYSTEM

K113697 is the FDA 510(k) clearance for EIGR SURGICAL ILLUMINATION SYSTEM by Invuity, Inc.. It is a Class 2 General & Plastic Surgery device (product code FST) cleared through the Special 510(k) pathway after a 56-day FDA review.

K113697 · Invuity, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2012
Decision
56d
Days
Class 2
Risk

K113697 is an FDA 510(k) clearance for the EIGR SURGICAL ILLUMINATION SYSTEM. Classified as Light, Surgical, Fiberoptic (product code FST), Class II - Special Controls.

Submitted by Invuity, Inc. (San Franciso, US). The FDA issued a Cleared decision on February 10, 2012 after a review of 56 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4580 - 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 Invuity, Inc. devices

Submission Details

510(k) Number K113697 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 115d · This submission: 56d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code FST Light, Surgical, Fiberoptic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4580
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - FST Light, Surgical, Fiberoptic

All 16
Devices cleared under the same product code (FST) and FDA review panel - the closest regulatory comparables to K113697.
TruView Light Cable, TruView Lateral Retractor Light Cable, Bifurcated Light Cable With Universal End
K200874 · Innovasis, Inc. · Jun 2020
LITE DECOMPRESSION SYSTEM- LIGHT CABLE MODEL 48089999
K122637 · Stryker Spine · Nov 2012
HARMONY VLED SURGICAL LIGHTNING SYSTEM
K100395 · STERIS Corporation · Mar 2010
AXXION LIGHT GUIDE
K082992 · Spinal Elements, Inc. · Feb 2009
ZIMMER MIS LIGHT
K080367 · Zimmer Spine, Inc. · Feb 2008
PROXENON 350, MODEL 902XX
K071218 · Welch Allyn, Inc. · Jun 2007