SpeediCath Compact Set
K-Number: K192904 · 2020-11-02
ApplicantColoplast
Decision Date2020-11-02
Product CodeGBM
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
SpeediCath Compact Set is a medical device manufactured by Coloplast. It received FDA 510(k) clearance on 2020-11-02 under approval number K192904. 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 Compact Set?
SpeediCath Compact Set is a medical device that received FDA 510(k) clearance on 2020-11-02. It is manufactured by Coloplast. The 510(k) number is K192904.
When was SpeediCath Compact Set approved by the FDA?
SpeediCath Compact Set received FDA 510(k) clearance on 2020-11-02, under approval number K192904.
What company makes SpeediCath Compact Set?
SpeediCath Compact Set is manufactured by Coloplast.
What is the FDA product code for SpeediCath Compact Set?
The FDA product code for SpeediCath Compact Set is GBM.
Related Clinical Trials
Other Devices by Coloplast
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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.