SpeediCath Standard
K-Number: K180258 · 2018-10-25
ApplicantColoplast
Decision Date2018-10-25
Product CodeGBM
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
SpeediCath Standard is a medical device manufactured by Coloplast. It received FDA 510(k) clearance on 2018-10-25 under approval number K180258. The device is classified under product code GBM. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the SpeediCath Standard?
SpeediCath Standard is a medical device that received FDA 510(k) clearance on 2018-10-25. It is manufactured by Coloplast. The 510(k) number is K180258.
When was SpeediCath Standard approved by the FDA?
SpeediCath Standard received FDA 510(k) clearance on 2018-10-25, under approval number K180258.
What company makes SpeediCath Standard?
SpeediCath Standard is manufactured by Coloplast.
What is the FDA product code for SpeediCath Standard?
The FDA product code for SpeediCath Standard is GBM.
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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.