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FDA 510(k)

KARL STORZ Endoscopic ICG Imaging System

K-Number: K152583 · 2016-05-31

ApplicantKARL STORZ Endoscopy-America, Inc.
Decision Date2016-05-31
Product CodeOWN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

KARL STORZ Endoscopic ICG Imaging System is a medical device manufactured by KARL STORZ Endoscopy-America, Inc.. It received FDA 510(k) clearance on 2016-05-31 under approval number K152583. 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 Endoscopic ICG Imaging System?

KARL STORZ Endoscopic ICG Imaging System is a medical device that received FDA 510(k) clearance on 2016-05-31. It is manufactured by KARL STORZ Endoscopy-America, Inc.. The 510(k) number is K152583.

When was KARL STORZ Endoscopic ICG Imaging System approved by the FDA?

KARL STORZ Endoscopic ICG Imaging System received FDA 510(k) clearance on 2016-05-31, under approval number K152583.

What company makes KARL STORZ Endoscopic ICG Imaging System?

KARL STORZ Endoscopic ICG Imaging System is manufactured by KARL STORZ Endoscopy-America, Inc..

What is the FDA product code for KARL STORZ Endoscopic ICG Imaging System?

The FDA product code for KARL STORZ Endoscopic ICG Imaging System is OWN.

Related Clinical Trials

NCT01143454 Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System RECRUITING NCT03331380 Technical Development of Cardiovascular Magnetic Resonance Imaging (CMR) Using a Low Specific Absorption Rate (SAR) Scanner System RECRUITING NCT07276815 OverStitch NXT Endoscopic Suture System NOT_YET_RECRUITING NCT04981223 Predicting Location and Extent of Prostate Cancer Using Micro-Ultrasound Imaging COMPLETED NCT07608614 Sleep and Performance RECRUITING NCT06861309 Placental Imaging Techniques RECRUITING

Related PubMed Literature

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)

Other Devices by KARL STORZ Endoscopy-America, Inc.

K161112KARL STORZ Flexible Video-Neuro-Endoscope System K171717AUTOCON III 400 K171238KARL STORZ ICG Imaging System K170462KARL STORZ ShuntScope K161554ENDOFLATOR 40, ENDOFLATOR 50 K162882KARL STORZ ICG Imaging System

View all 21 devices →

Related Devices (Code: OWN)

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. K162885SPY Phi Open Field Handheld Fluorescence Imaging SystemNovadaq Technologies, 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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