ViziShot 2 FLEX
K-Number: K163469 · 2017-04-06
Decision Date2017-04-06
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 2017-04-06 under approval number K163469. 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 2017-04-06. It is manufactured by Olympus Surgical Technologies America. The 510(k) number is K163469.
When was ViziShot 2 FLEX approved by the FDA?
ViziShot 2 FLEX received FDA 510(k) clearance on 2017-04-06, under approval number K163469.
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.
Other Devices by Olympus Surgical Technologies America
K171232PeriView FLEX
K181193PeriView FLEX
K183647SOLTIVE Laser System(SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVELaser Fibers, and Accessories)
K190164CleverLock Guidewire Locking Device and Biopsy Cap
K193517ViziShot 2 FLEX
K212643POWERSEAL Curved Jaw Sealer and Divider, Double Action
Related Devices (Code: KTI)
K161392Elation Pulmonary Balloon DilationMerit Medical Systems, Inc.
K153484Dillard Airway Dilatation SystemIntuit Medical Products, LLC
K152922ViziShot FLEXSpiration, Inc.
K171232PeriView FLEXOlympus Surgical Technologies America
K170759CRE Pulmonary Balloon Dilatation CatheterBoston Scientific Corporation
K181193PeriView FLEXOlympus Surgical Technologies America
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.