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FDA 510(k)

ViziShot 2 FLEX

K-Number: K193517 · 2020-03-18

ApplicantOlympus Surgical Technologies America
Decision Date2020-03-18
Product CodeKTI
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

ViziShot 2 FLEX is the device name listed in this FDA 510(k) record. The listed applicant is Olympus Surgical Technologies America. It received FDA 510(k) clearance on 2020-03-18 under 510(k) 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. The listed applicant is Olympus Surgical Technologies America. The 510(k) number is K193517.

When did ViziShot 2 FLEX receive FDA 510(k) clearance?

ViziShot 2 FLEX received FDA 510(k) clearance on 2020-03-18, under 510(k) number K193517.

Who is the listed applicant for ViziShot 2 FLEX?

The FDA 510(k) record lists Olympus Surgical Technologies America as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ViziShot 2 FLEX?

The FDA product code for ViziShot 2 FLEX is KTI.

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Related Devices (Code: KTI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.

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