Irrigation Tubing with CO2 or Air
K-Number: K193250 · 2020-04-06
Decision Date2020-04-06
Product CodeOCX
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
Irrigation Tubing with CO2 or Air is a medical device manufactured by Keymed (Medical and Industrial Equipment) , Ltd.. It received FDA 510(k) clearance on 2020-04-06 under approval number K193250. The device is classified under product code OCX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Irrigation Tubing with CO2 or Air?
Irrigation Tubing with CO2 or Air is a medical device that received FDA 510(k) clearance on 2020-04-06. It is manufactured by Keymed (Medical and Industrial Equipment) , Ltd.. The 510(k) number is K193250.
When was Irrigation Tubing with CO2 or Air approved by the FDA?
Irrigation Tubing with CO2 or Air received FDA 510(k) clearance on 2020-04-06, under approval number K193250.
What company makes Irrigation Tubing with CO2 or Air?
Irrigation Tubing with CO2 or Air is manufactured by Keymed (Medical and Industrial Equipment) , Ltd..
What is the FDA product code for Irrigation Tubing with CO2 or Air?
The FDA product code for Irrigation Tubing with CO2 or Air is OCX.
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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.