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FDA 510(k)

OC-FLEX Flexible IntraOral Cannula

K-Number: K161250 · 2017-03-17

ApplicantVenture Therapeutics, Inc.
Decision Date2017-03-17
Product CodeCCK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

OC-FLEX Flexible IntraOral Cannula is the device name listed in this FDA 510(k) record. The listed applicant is Venture Therapeutics, Inc.. It received FDA 510(k) clearance on 2017-03-17 under 510(k) number K161250. The device is classified under product code CCK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OC-FLEX Flexible IntraOral Cannula?

OC-FLEX Flexible IntraOral Cannula is a medical device that received FDA 510(k) clearance on 2017-03-17. The listed applicant is Venture Therapeutics, Inc.. The 510(k) number is K161250.

When did OC-FLEX Flexible IntraOral Cannula receive FDA 510(k) clearance?

OC-FLEX Flexible IntraOral Cannula received FDA 510(k) clearance on 2017-03-17, under 510(k) number K161250.

Who is the listed applicant for OC-FLEX Flexible IntraOral Cannula?

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

What is the FDA product code for OC-FLEX Flexible IntraOral Cannula?

The FDA product code for OC-FLEX Flexible IntraOral Cannula is CCK.

Related Devices (Code: CCK)

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.

K251641GF-310R Multigas Unit (GF-310R)Nihon Kohden CorporationK261633VisuBreathAffirm Medical Technologies II, LLCK253030Capnostream™35 Portable Respiratory Monitor (PM35MN)Covidien, LLCK250148Medical Gas Analyzer (AG200)Prior Care Science Technology, Ltd.K243956TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG-980P1)Nihon Kohden CorporationK2512160184 CO2 Sampling line; 0184T CO2 Sampling line; 0139 CO2 Sampling line; 0182 CO2 Sampling lineBarbaras Development, Inc.

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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