# K201399: HOPKINS ICG/NIR 10mm Ridgid Endoscope (modified) 0°, 30°, 45°, HOPKIN ICG/NIR 5mm Ridgid Endoscope (modified) 0°, 30°, 45°, HOPKIN ICG/NIR 4mm Ridgid Endoscope 0°, 30°, 45°, VITOM II ICG/NIR Telescope, Power LED Rubina Light Source, Foot Switch, Fiber Optic Light Cable, Image S CCU, Image S 4U Rubina Camera Head

- Pathway: 510(k) (Traditional)
- Applicant: Karl Storz-Endoscopy-America, Inc.
- Decided: Aug 17, 2020 after 81 days
- Product code: OWN (Confocal Optical Imaging)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 17 generations back to K930667 (1994). 94 ancestors in all.
8 later devices descend from it; 1 cites it directly.
0 of 103 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180146: KARL STORZ ICG Imaging System, Karl Storz Endoscopy America, Inc. (2018) Summary page 4.

## Most influential descendants
- K202925: KARL STORZ ICG Imaging System (2020), 7 descendants of its own
- K212695: KARL STORZ ICG Imaging System (2021), 5 descendants of its own
- K233333: KARL STORZ ICG Imaging System, KARL STORZ Image1S Camera Control Unit (2023), 2 descendants of its own
- K262547: KARL STORZ TIPCAM1 Rubina (2026), 0 descendants of its own
- K254242: KARL STORZ ICG Imaging System with RUBINA® Lens (2026), 0 descendants of its own

## Indications for use
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, and 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.

Source page: https://510kreport.com/device/K201399
Methodology: https://510kreport.com/methodology