KARL STORZ ICG Imaging System
K-Number: K162882 · 2017-01-26
ApplicantKARL STORZ Endoscopy-America, Inc.
Decision Date2017-01-26
Product CodeOWN
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
KARL STORZ ICG Imaging System is a medical device manufactured by KARL STORZ Endoscopy-America, Inc.. It received FDA 510(k) clearance on 2017-01-26 under approval number K162882. 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?
KARL STORZ ICG Imaging System is a medical device that received FDA 510(k) clearance on 2017-01-26. It is manufactured by KARL STORZ Endoscopy-America, Inc.. The 510(k) number is K162882.
When was KARL STORZ ICG Imaging System approved by the FDA?
KARL STORZ ICG Imaging System received FDA 510(k) clearance on 2017-01-26, under approval number K162882.
What company makes KARL STORZ ICG Imaging System?
KARL STORZ ICG Imaging System is manufactured by KARL STORZ Endoscopy-America, Inc..
What is the FDA product code for KARL STORZ ICG Imaging System?
The FDA product code for KARL STORZ ICG Imaging System is OWN.
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Other Devices by KARL STORZ Endoscopy-America, Inc.
Related Devices (Code: OWN)
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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.