ViziShot 2 FLEX
K-Number: K193517 · 2020-03-18
Decision Date2020-03-18
Product CodeKTI
Advisory CommitteeEN
DecisionSubstantially Equivalent
Device Summary
ViziShot 2 FLEX is a medical device manufactured by Olympus Surgical Technologies America. It received FDA 510(k) clearance on 2020-03-18 under approval number K193517. The device is classified under product code KTI. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the ViziShot 2 FLEX?
ViziShot 2 FLEX is a medical device that received FDA 510(k) clearance on 2020-03-18. It is manufactured by Olympus Surgical Technologies America. The 510(k) number is K193517.
When was ViziShot 2 FLEX approved by the FDA?
ViziShot 2 FLEX received FDA 510(k) clearance on 2020-03-18, under approval number K193517.
What company makes ViziShot 2 FLEX?
ViziShot 2 FLEX is manufactured by Olympus Surgical Technologies America.
What is the FDA product code for ViziShot 2 FLEX?
The FDA product code for ViziShot 2 FLEX is KTI.
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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.