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FDA 510(k)

ViziShot FLEX

K-Number: K152922 · 2016-02-19

ApplicantSpiration, Inc.
Decision Date2016-02-19
Product CodeKTI
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

ViziShot FLEX is the device name listed in this FDA 510(k) record. The listed applicant is Spiration, Inc.. It received FDA 510(k) clearance on 2016-02-19 under 510(k) number K152922. 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 FLEX?

ViziShot FLEX is a medical device that received FDA 510(k) clearance on 2016-02-19. The listed applicant is Spiration, Inc.. The 510(k) number is K152922.

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

ViziShot FLEX received FDA 510(k) clearance on 2016-02-19, under 510(k) number K152922.

Who is the listed applicant for ViziShot FLEX?

The FDA 510(k) record lists Spiration, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ViziShot FLEX?

The FDA product code for ViziShot FLEX is KTI.

Other records listing Spiration, Inc. as applicant

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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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.

K261274EchoTip Ultra® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes; EchoTip ProCore® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm ScopesCook Ireland, Ltd.K251478ClearTip TBNA TypeFinemedix Co., Ltd.K254040LungFlow Basket CatheterFree Flow Medical, Inc.K251402LIA-1 Catheter (542-1)Leadoptik, Inc.K252874Compass Steerable Needle with Adapters SRA-1-01 and SRA-2-01Serpex Medical, Inc.K251664Single Use Aspiration Needle (NA-201SX-4021); Single Use Aspiration Needle (NA-201SX-4022)Olympus Medical Systems Corporation

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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