510(k) Report

510(k) · Cleared

Cleared

KARL STORZ ICG Imaging System

K180146510(k) TraditionalCleared Apr 17, 201889-day reviewClass II21 CFR 882.1480

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

Karl Storz Endoscopy America, Inc. · GWG Endoscope, Neurological

Cleared on Apr 17, 2018 as substantially equivalent to K171238 (KARL STORZ Endoscopy-America, Inc., 2017) and 2 other predicates after an 89-day review. Its family tree reaches back 16 generations to 1994. 30 later devices descend from it.

Decided
Apr 17, 2018
Review
89 days
Class
Class II
Product code
GWG
Recalls
None
Predicates
3

Its longest line of descent runs back 16 generations to K930667 (1994). 93 ancestors in all, the oldest K811390 (1981). 30 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2002: 5 other ancestors2015: 2 other ancestors2014: 1 other ancestor2013: 2 other ancestors2009: 1 other ancestor2008: 4 other ancestors2007: 3 other ancestors2006: 3 other ancestors2001: 6 other ancestors1998: 4 other ancestors1991: 3 other ancestors2005: 4 other ancestors2003: 1 other ancestor2000: 2 other ancestors1999: 6 other ancestors1997: 10 other ancestors1996: 2 other ancestors1995: 5 other ancestors1994: 4 other ancestors1992: 2 other ancestors2004: 3 other ancestors1993: 2 other ancestors1988: 1 other ancestor1981: 1 other ancestor2024: 4 descendants cleared2021: 3 descendants cleared2020: 2 descendants cleared2022: 4 descendants cleared2026: 8 descendants cleared2023: 6 descendants cleared2025: 3 descendants clearedK930667 · Reusable Laparoscopic Instruments · Snowden-Pencer · 1994 · recalledK960400 · Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line Instruments/Diamond-Port (Access Parts) · Snowden-Pencer · 1996K990144 · Intuitive Surgical Endoscopic Instruments, Intuitive Surgical Endoscopic Instrument Control System · Intuitive Surgical, Inc. · 2000 · recalledK021036 · Intuitive Surgical DA Vinci Surgical System, Model IS1000 · Intuitive Surgical, Inc. · 2002 · recalled×5: 5 generations cleared close together, K040237 (2004), K043153 (2004), K050005 (2005), K050404 (2005), K050802 (2005) K063220 · DA Vinci S Surgical System-V1.1, Model IS2000 · Intuitive Surgical, Inc. · 2006 · recalledK081137 · Intuitive Surgical DA Vinci SI Surgical System: Model IS3000 · Intuitive Surgical, Inc. · 2009 · recalledK101077 · DA Vinci Fluorescence Imaging Vision System, Model FF 100 · Intuitive Surgical, Inc. · 2011 · recalledK124031 · DA Vinci Fluorescence Imaging Vision System · Intuitive Surgical, Inc. · 2013K152583 · KARL STORZ Endoscopic ICG Imaging System · KARL STORZ Endoscopy-America, Inc. · 2016×2: 2 generations cleared close together, K162882 (2017), K171238 (2017) 19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 1 other ancestor3 generations back: 5 other ancestors4 generations back: 11 other ancestors5 generations back: 14 other ancestors6 generations back: 8 other ancestors7 generations back: 8 other ancestors8 generations back: 9 other ancestors9 generations back: 9 other ancestors10 generations back: 6 other ancestors11 generations back: 5 other ancestors 1 generation forward: 4 descendants2 generations forward: 9 descendants3 generations forward: 7 descendants4 generations forward: 3 descendants5 generations forward: 6 descendants6 generations forward: 1 descendant K171238 · KARL STORZ ICG Imaging System · KARL STORZ Endoscopy-America, Inc. · 2017K162882 · KARL STORZ ICG Imaging System · KARL STORZ Endoscopy-America, Inc. · 2017K152583 · KARL STORZ Endoscopic ICG Imaging System · KARL STORZ Endoscopy-America, Inc. · 2016K124031 · DA Vinci Fluorescence Imaging Vision System · Intuitive Surgical, Inc. · 2013K101077 · DA Vinci Fluorescence Imaging Vision System, Model FF 100 · Intuitive Surgical, Inc. · 2011 · recalledK081137 · Intuitive Surgical DA Vinci SI Surgical System: Model IS3000 · Intuitive Surgical, Inc. · 2009 · recalledK063220 · DA Vinci S Surgical System-V1.1, Model IS2000 · Intuitive Surgical, Inc. · 2006 · recalledK050802 · Modification to Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments · Intuitive Surgical, Inc. · 2005K050404 · Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments · Intuitive Surgical, Inc. · 2005K050005 · Intuitive Surgical Monopolar Curved Scissors, Model 400179; Tip Cover Accessory, Model 400180 · Intuitive Surgical, Inc. · 2005 · recalledK043153 · Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments, Models IS1200 & IS1000 · Intuitive Surgical, Inc. · 2004K040237 · Intuitive Surgical DA Vinci Endoscopic Instrument Control System and Endoscopic Instruments · Intuitive Surgical, Inc. · 2004K021036 · Intuitive Surgical DA Vinci Surgical System, Model IS1000 · Intuitive Surgical, Inc. · 2002 · recalledK990144 · Intuitive Surgical Endoscopic Instruments, Intuitive Surgical Endoscopic Instrument Control System · Intuitive Surgical, Inc. · 2000 · recalledK960400 · Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line Instruments/Diamond-Port (Access Parts) · Snowden-Pencer · 1996K930667 · Reusable Laparoscopic Instruments · Snowden-Pencer · 1994 · recalled−15−10−50+5
  1. Root · 16 generations backK930667 Reusable Laparoscopic InstrumentsSnowden-Pencer · 1994 · Recalled
  2. 12 generations between
  3. 3 generations backK152583 KARL STORZ Endoscopic ICG Imaging SystemKARL STORZ Endoscopy-America, Inc. · 2016
  4. 2 generations backK162882 KARL STORZ ICG Imaging SystemKARL STORZ Endoscopy-America, Inc. · 2017
  5. 1 generation backK171238 KARL STORZ ICG Imaging SystemKARL STORZ Endoscopy-America, Inc. · 2017
  6. This deviceK180146 KARL STORZ ICG Imaging SystemKarl Storz Endoscopy America, Inc. · 2018
  7. Descendant · cites it directly · 19 of its ownK211202 1688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight…Stryker · 2021
  8. Descendant · 2 generations on · 14 of its ownK214046 780 nm 1688 4K Camera System, 780 nm L11 LED Light Source with AIM…Stryker · 2022
  9. Descendant · 3 generations on · 10 of its ownK221611 780 nm L11 LED Light Source with AIMStryker · 2022
  10. Descendant · 3 generations on · 8 of its ownK230216 1688 4K Camera Control Unit with Advanced Imaging Modality…Stryker · 2023
  11. Descendant · cites it directly · 8 of its ownK201399 HOPKINS ICG/NIR 10mm Ridgid Endoscope (modified) 0°, 30°, 45°…Karl Storz-Endoscopy-America, Inc. · 2020
Show all 16 generations
  1. Root · 16 generations backK930667 Reusable Laparoscopic InstrumentsSnowden-Pencer · 1994 · Recalled
  2. 15 generations backK960400 Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line…Snowden-Pencer · 1996
  3. 14 generations backK990144 Intuitive Surgical Endoscopic Instruments, Intuitive Surgical…Intuitive Surgical, Inc. · 2000 · Recalled
  4. 13 generations backK021036 Intuitive Surgical DA Vinci Surgical System, Model IS1000Intuitive Surgical, Inc. · 2002 · Recalled
  5. 12 generations backK040237 Intuitive Surgical DA Vinci Endoscopic Instrument Control System and…Intuitive Surgical, Inc. · 2004
  6. 11 generations backK043153 Intuitive Surgical DA Vinci Surgical System and Endoscopic…Intuitive Surgical, Inc. · 2004
  7. 10 generations backK050005 Intuitive Surgical Monopolar Curved Scissors, Model 400179; Tip…Intuitive Surgical, Inc. · 2005 · Recalled
  8. 9 generations backK050404 Intuitive Surgical DA Vinci Surgical System and Endoscopic InstrumentsIntuitive Surgical, Inc. · 2005
  9. 8 generations backK050802 Modification to Intuitive Surgical DA Vinci Surgical System and…Intuitive Surgical, Inc. · 2005
  10. 7 generations backK063220 DA Vinci S Surgical System-V1.1, Model IS2000Intuitive Surgical, Inc. · 2006 · Recalled
  11. 6 generations backK081137 Intuitive Surgical DA Vinci SI Surgical System: Model IS3000Intuitive Surgical, Inc. · 2009 · Recalled
  12. 5 generations backK101077 DA Vinci Fluorescence Imaging Vision System, Model FF 100Intuitive Surgical, Inc. · 2011 · Recalled
  13. 4 generations backK124031 DA Vinci Fluorescence Imaging Vision SystemIntuitive Surgical, Inc. · 2013
  14. 3 generations backK152583 KARL STORZ Endoscopic ICG Imaging SystemKARL STORZ Endoscopy-America, Inc. · 2016
  15. 2 generations backK162882 KARL STORZ ICG Imaging SystemKARL STORZ Endoscopy-America, Inc. · 2017
  16. 1 generation backK171238 KARL STORZ ICG Imaging SystemKARL STORZ Endoscopy-America, Inc. · 2017
  17. This deviceK180146 KARL STORZ ICG Imaging SystemKarl Storz Endoscopy America, Inc. · 2018

Showing 5 of 30 descendants. See all descendants

Descendants cleared per year

2020: 22021: 32022: 42023: 62024: 42025: 32026: 8
2020high 8 (2026) · low 2 (2020)2026

Most influential descendants

Showing 5 of 30 · See all
  • K2112021688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, Precision S…Stryker · 2021 · cites it directly19descendants
  • K214046780 nm 1688 4K Camera System, 780 nm L11 LED Light Source with AIM and Safelight CableStryker · 2022 · 2 generations on14descendants
  • K221611780 nm L11 LED Light Source with AIMStryker · 2022 · 3 generations on10descendants
  • K2302161688 4K Camera Control Unit with Advanced Imaging Modality (1688010000)Stryker · 2023 · 3 generations on8descendants
  • K201399HOPKINS ICG/NIR 10mm Ridgid Endoscope (modified) 0°, 30°, 45°, HOPKIN ICG/NIR 5mm Ridgid…Karl Storz-Endoscopy-America, Inc. · 2020 · cites it directly8descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−16K930667Reusable Laparoscopic InstrumentsSnowden-Pencer199415
−15K960400Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line…Snowden-Pencer1996—
−14K990144Intuitive Surgical Endoscopic Instruments, Intuitive Surgical Endoscopic…Intuitive Surgical, Inc.20003
−13K021036Intuitive Surgical DA Vinci Surgical System, Model IS1000Intuitive Surgical, Inc.200218
−12K040237Intuitive Surgical DA Vinci Endoscopic Instrument Control System and…Intuitive Surgical, Inc.2004—
−11K043153Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments, Models…Intuitive Surgical, Inc.2004—
−10K050005Intuitive Surgical Monopolar Curved Scissors, Model 400179; Tip Cover…Intuitive Surgical, Inc.20052
−9K050404Intuitive Surgical DA Vinci Surgical System and Endoscopic InstrumentsIntuitive Surgical, Inc.2005—
−8K050802Modification to Intuitive Surgical DA Vinci Surgical System and Endoscopic…Intuitive Surgical, Inc.2005—
−7K063220DA Vinci S Surgical System-V1.1, Model IS2000Intuitive Surgical, Inc.20064
−6K081137Intuitive Surgical DA Vinci SI Surgical System: Model IS3000Intuitive Surgical, Inc.200925
−5K101077DA Vinci Fluorescence Imaging Vision System, Model FF 100Intuitive Surgical, Inc.20112
−4K124031DA Vinci Fluorescence Imaging Vision SystemIntuitive Surgical, Inc.2013—
−3K152583KARL STORZ Endoscopic ICG Imaging SystemKARL STORZ Endoscopy-America, Inc.2016—
−2K162882KARL STORZ ICG Imaging SystemKARL STORZ Endoscopy-America, Inc.2017—
−1K171238KARL STORZ ICG Imaging SystemKARL STORZ Endoscopy-America, Inc.2017—
0 (this device)K180146KARL STORZ ICG Imaging SystemKarl Storz Endoscopy America, Inc.2018—
+1K2112021688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable…Stryker2021—
+2K214046780 nm 1688 4K Camera System, 780 nm L11 LED Light Source with AIM and…Stryker2022—
+3K221611780 nm L11 LED Light Source with AIMStryker2022—
+3K2302161688 4K Camera Control Unit with Advanced Imaging Modality (1688010000)Stryker2023—
+1K201399HOPKINS ICG/NIR 10mm Ridgid Endoscope (modified) 0°, 30°, 45°, HOPKIN ICG/NIR…Karl Storz-Endoscopy-America, Inc.2020—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198110
198810
199130
199220
199320
199440
199550
199620
1997100
199840
199960
200020
200160
200250
200310
200430
200540
200630
200730
200840
200910
201320
201410
201520

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202020
202130
202240
202360
202440
202530
202680
FIG. 1 — Lineage of K180146, 1994–2026Source: 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 summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in GWG? 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 GWG device

  1. #1 K211202 1688 4K Camera System, L11 LED Light Source…score 22.5 · 20 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (3)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K171238KARL STORZ ICG Imaging System
Summary page 4
…ogical Endoscope Product Code: GWG, OWN Regulation: 21 CFR 876.1480 (Neurological Endoscope) Predicate Device(s): KARL STORZ ICG Imaging System (K171238) – Primary KSEA Neuroendoscopes and Accessories (K021050) – Secondary **The above p…
KARL STORZ Endoscopy-America, Inc.2017—
*K021050Ksea Neuroendoscopes and Accessories
Summary page 4
…876.1480 (Neurological Endoscope) Predicate Device(s): KARL STORZ ICG Imaging System (K171238) – Primary KSEA Neuroendoscopes and Accessories (K021050) – Secondary **The above predicate has not been subject to any recall** The KARL S…
KARL STORZ Endoscopy-America, Inc.2002—
*K162882KARL STORZ ICG Imaging System
Summary page 9
…Device Predicate Predicate Device Device K162882 K021050 (D1) Rigid, rod lens Rigid, rod lens Rigid, rod Endoscope…
KARL STORZ Endoscopy-America, Inc.2017—

What descends from it? (30)

See all 30

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K2112021688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, Precision S…Stryker202119
K201399HOPKINS ICG/NIR 10mm Ridgid Endoscope (modified) 0°, 30°, 45°, HOPKIN ICG/NIR 5mm Ridgid…Karl Storz-Endoscopy-America, Inc.20208
K212695KARL STORZ ICG Imaging SystemKarl Storz Endoscopy America20215
K233391cCeLL - In vivoVPIX Medical, Inc.20240

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?

  • The line of descent spans 24 years and passes through 4 companies; a new generation was cleared every 1.8 years on median.
  • 19 of the 93 ancestors have a recall of any class.
  • Of its descendants, K211202 (Stryker, 2021) has gone furthest, with 19 descendants of its own.

How does its category compare?

All GWG devices

GWG Endoscope, Neurological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.

FDA decisions per year · GWG

2in 2025

2008: 22013: 12014: 22016: 22017: 42018: 42019: 32020: 22021: 32023: 52024: 12025: 22026 (partial year): 4
2007high 5 (2023) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GWG

269in 2023

2017: 126 days median2018: 128 days median2019: 156 days median2021: 106 days median2023: 269 days median2026 (partial year): 217 days median
2007high 269 (2023) · low 106 (2021)2026

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

Recalls per year · GWG

2in 2011

2009: 12011: 2
2007high 2 (2011) · low 0 (2007)2026

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

Adverse event reports per year · GWG

33in 2025

2007: 32008: 52010: 12011: 42012: 72013: 32014: 192015: 372016: 252017: 122018: 162019: 102020: 192021: 212022: 122023: 92024: 92025: 33
2007high 37 (2015) · low 0 (2009)2025

MAUDE reports naming product code GWG, 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
20070—03
20082—05
20090—10
20100—01
20110—24
20120—07
20131—03
20142—019
20150—037
20162—025
20174126012
20184128016
20193156010
20202—019
20213106021
20220—012
2023526909
20241—09
20252—033
202642170—

What is it indicated for?

The KARL STORZ ICG Imaging System is intended to provide real-time visible (VIS) and near-infrared (NIR) fluorescence imaging. The KARL STORZ Endoscopic ICG System enables surgeons to perform minimally invasive surgery using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion, or at least one of the major extra-hepatic bile ducts (cystic duct, common bile duct and common hepatic duct), using…

Read the full statement (235 words)

The KARL STORZ ICG Imaging System is intended to provide real-time visible (VIS) and near-infrared (NIR) fluorescence imaging.

The KARL STORZ Endoscopic ICG System enables surgeons to perform minimally invasive surgery using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion, or at least one of the major extra-hepatic bile ducts (cystic duct, common bile duct and common hepatic duct), using near infrared imaging. Fluorescence imaging of biliary ducts with the KARL STORZ Endoscopic ICG System is intended for use with standard of care white light and, when indicated, intraoperative cholangiography. The device is not intended for standalone use for biliary duct visualization.

Additionally, the KARL STORZ Endoscopic ICG System enables surgeon to perform minimally invasive cranial neurosurgery in adults and pediatrics and endonasal skull base surgery in adults and pediatrics > 6 years of age using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion using near infrared imaging.

The KARL STORZ VITOM II ICG System is intended for capturing and viewing fluorescent images for the visual assessment of blood flow, as an adjunctive method for the evaluation of tissue perfusion, and related tissue-transfer circulation in tissue and free flaps used in plastic, micro- and reconstructive surgical procedures. The VITOM II ICG System is intended to provide a magnified view of the surgical field in standard white light.

Indications for use as stated in the FDA summary.

More from Karl Storz Endoscopy America, Inc.

25 FDA decisions under this applicant name. See the company

  • K240506KARL STORZ HoldersKarl Storz Endoscopy America, Inc. · 2024
  • K223885HOPKINS TelescopesKarl Storz Endoscopy America, Inc. · 2023
  • K230359KOH Ultramicro Injection Cannula (26167NN); Suction a. Irrig. Cannula,L. 36cm (37360CP); Suction a. Irrig.…Karl Storz Endoscopy America, Inc. · 2023
  • K221893KARL STORZ Bipolar Resectoscopes with HF CableKarl Storz Endoscopy America, Inc. · 2023
  • K221004HOPKINS TelescopesKarl Storz Endoscopy America, Inc. · 2022

Recent decisions in GWG

The GWG category page

  • K260315cCeLL - In vivoVPIX Medical, Inc. · 2026
  • K260581KARL STORZ Flexible Video Neuro-EndoscopeKarl Storz SE & CO. KG · 2026
  • K253602Precision S 4K SinuscopeStryker Endoscopy · 2026
  • K253679Hydro Irrigation SystemStryker Instruments · 2026
  • K243429HJY VisualNext 3D Endoscopic Vision SystemHjy Smart Medical Device Co., Ltd. · 2025

https://510kreport.com/device/K180146 · printed Nov 6, 2026

Cite this page

510(k) Report. “K180146: KARL STORZ ICG Imaging System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180146

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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