Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

OC-FLEX Flexible IntraOral Cannula

K-Number: K161250 · 2017-03-17

Decision Date2017-03-17
Product CodeCCK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

OC-FLEX Flexible IntraOral Cannula is a medical device manufactured by Venture Therapeutics, Inc.. It received FDA 510(k) clearance on 2017-03-17 under approval 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. It is manufactured by Venture Therapeutics, Inc.. The 510(k) number is K161250.

When was OC-FLEX Flexible IntraOral Cannula approved by the FDA?

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

What company makes OC-FLEX Flexible IntraOral Cannula?

OC-FLEX Flexible IntraOral Cannula is manufactured by Venture Therapeutics, Inc..

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)

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.