SpeediCath Flex Set
K-Number: K222059 · 2022-09-21
ApplicantColoplast
Decision Date2022-09-21
Product CodeEZD
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
SpeediCath Flex Set is a medical device manufactured by Coloplast. It received FDA 510(k) clearance on 2022-09-21 under approval number K222059. The device is classified under product code EZD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the SpeediCath Flex Set?
SpeediCath Flex Set is a medical device that received FDA 510(k) clearance on 2022-09-21. It is manufactured by Coloplast. The 510(k) number is K222059.
When was SpeediCath Flex Set approved by the FDA?
SpeediCath Flex Set received FDA 510(k) clearance on 2022-09-21, under approval number K222059.
What company makes SpeediCath Flex Set?
SpeediCath Flex Set is manufactured by Coloplast.
What is the FDA product code for SpeediCath Flex Set?
The FDA product code for SpeediCath Flex Set is EZD.
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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.