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FDA 510(k)

KARL STORZ ICG Imaging System with RUBINA® Lens

K-Number: K254242 · 2026-02-26

ApplicantKarl Storz SE & CO. KG
Decision Date2026-02-26
Product CodeOWN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

KARL STORZ ICG Imaging System with RUBINA® Lens is a medical device manufactured by Karl Storz SE & CO. KG. It received FDA 510(k) clearance on 2026-02-26 under approval number K254242. The device is classified under product code OWN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KARL STORZ ICG Imaging System with RUBINA® Lens?

KARL STORZ ICG Imaging System with RUBINA® Lens is a medical device that received FDA 510(k) clearance on 2026-02-26. It is manufactured by Karl Storz SE & CO. KG. The 510(k) number is K254242.

When was KARL STORZ ICG Imaging System with RUBINA® Lens approved by the FDA?

KARL STORZ ICG Imaging System with RUBINA® Lens received FDA 510(k) clearance on 2026-02-26, under approval number K254242.

What company makes KARL STORZ ICG Imaging System with RUBINA® Lens?

KARL STORZ ICG Imaging System with RUBINA® Lens is manufactured by Karl Storz SE & CO. KG.

What is the FDA product code for KARL STORZ ICG Imaging System with RUBINA® Lens?

The FDA product code for KARL STORZ ICG Imaging System with RUBINA® Lens is OWN.

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Related PubMed Literature

PMID: 41887630 Capacity building for ethical use of artificial intelligence in health: protocol for a scoping review of training initiatives and gaps in Africa. BMJ open (2026) PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025) PMID: 40346298 An attempt to evaluate the use of mixed reality in surgically treated pediatric oncology patients. NPJ digital medicine (2025)

Other Devices by Karl Storz SE & CO. KG

K180735Endomat Select K201355Endomat Select, IBS Shaver Software, License K192090CMOS Video Rhino-Laryngoscope SSU K192523CMOS Video Esophagoscope SSU K233333KARL STORZ ICG Imaging System, KARL STORZ Image1S Camera Control Unit K232857KARL STORZ ICG Imaging System

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Related Devices (Code: OWN)

K152583KARL STORZ Endoscopic ICG Imaging SystemKARL STORZ Endoscopy-America, Inc. K160416CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) with Confocal MiniprobesMauna Kea Technologies K172844Cellvizio 100 Series System with Confocal MiniprobesMauna Kea Technologies K171345Cellvizio 100 Series Systems with Confocal MiniprobesMauna Kea Technologies K171238KARL STORZ ICG Imaging SystemKARL STORZ Endoscopy-America, Inc. K162882KARL STORZ ICG Imaging SystemKARL STORZ Endoscopy-America, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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