Cleared Special

EIGR SURGICAL ILLUMINATION SYSTEM (K113697) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K113697 · Invuity, Inc. · General & Plastic Surgery device
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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.