MedicloseTM System
K-Number: K213271 · 2023-08-31
Decision Date2023-08-31
Product CodeOCW
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
MedicloseTM System is a medical device manufactured by Health Value Creation B.V., Trading AS Corporis Medical. It received FDA 510(k) clearance on 2023-08-31 under approval number K213271. The device is classified under product code OCW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the MedicloseTM System?
MedicloseTM System is a medical device that received FDA 510(k) clearance on 2023-08-31. It is manufactured by Health Value Creation B.V., Trading AS Corporis Medical. The 510(k) number is K213271.
When was MedicloseTM System approved by the FDA?
MedicloseTM System received FDA 510(k) clearance on 2023-08-31, under approval number K213271.
What company makes MedicloseTM System?
MedicloseTM System is manufactured by Health Value Creation B.V., Trading AS Corporis Medical.
What is the FDA product code for MedicloseTM System?
The FDA product code for MedicloseTM System is OCW.
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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.