510(k) Report

510(k) · Cleared

Cleared

Eigr Surgical Illumination System

K113697510(k) SpecialCleared Feb 10, 201256-day reviewClass II21 CFR 878.4580

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Invuity, Inc. · FST Light, Surgical, Fiberoptic

Cleared on Feb 10, 2012 after a 56-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it.

Decided
Feb 10, 2012
Review
56 days
Class
Class II
Product code
FST
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2015: 1 descendant cleared2010201520202025
  1. This deviceK113697 Eigr Surgical Illumination SystemInvuity, Inc. · 2012
  2. Descendant · cites it directly · 0 of its ownK141781 Kogent Spetzler Lighted Suction TubesKatalyst Surgical, LLC · 2015

Most influential descendants

Showing 1 of 1 · See all
  • K141781Kogent Spetzler Lighted Suction TubesKatalyst Surgical, LLC · 2015 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K113697Eigr Surgical Illumination SystemInvuity, Inc.2012—
+1K141781Kogent Spetzler Lighted Suction TubesKatalyst Surgical, LLC2015—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201510
FIG. 1 — Lineage of K113697, 2012–2015Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in FST? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new FST device

  1. #1 K200874 TruView Light Cable, TruView Lateral Retractor…score -0.4 · 1 generation · no Class I recall
Get a 510(k) Report

What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K141781Kogent Spetzler Lighted Suction TubesKatalyst Surgical, LLC20150

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K141781 (Katalyst Surgical, LLC, 2015) has gone furthest, with 0 descendants of its own.

How does its category compare?

All FST devices

FST Light, Surgical, Fiberoptic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.

FDA decisions per year · FST

1in 2020

2007: 12008: 22009: 32010: 52012: 32014: 12020: 1
2007high 5 (2010) · low 0 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FST

59in 2012

2009: 100 days median2010: 90 days median2012: 59 days median
2007high 100 (2009) · low 59 (2012)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FST

1in 2014

2011: 102014: 1
2007high 10 (2011) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · FST

27in 2025

2007: 32008: 22009: 42010: 32011: 72012: 142013: 92014: 132015: 142016: 152017: 202018: 122019: 292020: 332021: 202022: 112023: 112024: 402025: 27
2007high 40 (2024) · low 2 (2008)2025

MAUDE reports naming product code FST, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—03
20082—02
2009310004
201059003
20110—107
2012359014
20130—09
20141—113
20150—014
20160—015
20170—020
20180—012
20190—029
20201—033
20210—020
20220—011
20230—011
20240—040
20250—027
20260—0—

What is it indicated for?

The Invuity® Eigr™ Surgical Illumination System is intended to provide surgical site illumination from a high intensity light source.

Indications for use as stated in the FDA 510(k) statement.

More from Invuity, Inc.

4 FDA decisions under this applicant name. See the company

  • K191583PhotonBlade with Smoke EvacuationInvuity, Inc. · 2020
  • K162053PhotonBladeInvuity, Inc. · 20161 recall
  • K090070Invuity Britefield Mcculloch Retractor SystemInvuity, Inc. · 2009

Recent decisions in FST

The FST category page

  • K200874TruView Light Cable, TruView Lateral Retractor Light Cable, Bifurcated Light Cable With Universal EndInnovasis, Inc. · 2020
  • K141330Endo-CordEnroxtech, Inc. · 2014
  • K122637Lite Decompression System- Light Cable Model 48089999Stryker Spine · 2012
  • K113330CablecapSensormed · 2012
  • K102266Isoled AC-Powered Led Headlight SystemIsolux, LLC · 2010

https://510kreport.com/device/K113697 · printed Nov 5, 2026

Cite this page

510(k) Report. “K113697: Eigr Surgical Illumination System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K113697

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026