hygh-tec Drainage II
K-Number: K242336 · 2025-01-17
ApplicantAmb Medtec
Decision Date2025-01-17
Product CodeKNT
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
hygh-tec Drainage II is a medical device manufactured by Amb Medtec. It received FDA 510(k) clearance on 2025-01-17 under approval number K242336. 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 II?
hygh-tec Drainage II is a medical device that received FDA 510(k) clearance on 2025-01-17. It is manufactured by Amb Medtec. The 510(k) number is K242336.
When was hygh-tec Drainage II approved by the FDA?
hygh-tec Drainage II received FDA 510(k) clearance on 2025-01-17, under approval number K242336.
What company makes hygh-tec Drainage II?
hygh-tec Drainage II is manufactured by Amb Medtec.
What is the FDA product code for hygh-tec Drainage II?
The FDA product code for hygh-tec Drainage II is KNT.
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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.