Decision Date2023-02-09
Product CodeKNT
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
hygh-tec drainage is a medical device manufactured by Creative Balloons GmbH. It received FDA 510(k) clearance on 2023-02-09 under approval number K221400. 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 hygh-tec drainage?
hygh-tec drainage is a medical device that received FDA 510(k) clearance on 2023-02-09. It is manufactured by Creative Balloons GmbH. The 510(k) number is K221400.
When was hygh-tec drainage approved by the FDA?
hygh-tec drainage received FDA 510(k) clearance on 2023-02-09, under approval number K221400.
What company makes hygh-tec drainage?
hygh-tec drainage is manufactured by Creative Balloons GmbH.
What is the FDA product code for hygh-tec drainage?
The FDA product code for hygh-tec drainage is KNT.
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Official Source
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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.