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FDA 510(k)

hygh-tec drainage

K-Number: K221400 · 2023-02-09

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.

Related Devices (Code: KNT)

Official Source

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