Flexi-Seal PROTECT Fecal Management System
K-Number: K162906 · 2017-03-07
ApplicantConvatec
Decision Date2017-03-07
Product CodeKNT
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
Flexi-Seal PROTECT Fecal Management System is a medical device manufactured by Convatec. It received FDA 510(k) clearance on 2017-03-07 under approval number K162906. The device is classified under product code KNT. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Flexi-Seal PROTECT Fecal Management System?
Flexi-Seal PROTECT Fecal Management System is a medical device that received FDA 510(k) clearance on 2017-03-07. It is manufactured by Convatec. The 510(k) number is K162906.
When was Flexi-Seal PROTECT Fecal Management System approved by the FDA?
Flexi-Seal PROTECT Fecal Management System received FDA 510(k) clearance on 2017-03-07, under approval number K162906.
What company makes Flexi-Seal PROTECT Fecal Management System?
Flexi-Seal PROTECT Fecal Management System is manufactured by Convatec.
What is the FDA product code for Flexi-Seal PROTECT Fecal Management System?
The FDA product code for Flexi-Seal PROTECT Fecal Management System is KNT.
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Other Devices by Convatec
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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.