KARL STORZ ICG Imaging System
K-Number: K180146 · 2018-04-17
ApplicantKarl Storz Endoscopy America, Inc.
Decision Date2018-04-17
Product CodeGWG
Advisory CommitteeNE
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 2018-04-17 under approval number K180146. The device is classified under product code GWG. It was reviewed by the NE 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 2018-04-17. It is manufactured by Karl Storz Endoscopy America, Inc.. The 510(k) number is K180146.
When was KARL STORZ ICG Imaging System approved by the FDA?
KARL STORZ ICG Imaging System received FDA 510(k) clearance on 2018-04-17, under approval number K180146.
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 GWG.
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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.