Sectum
K-Number: K202780 · 2021-07-30
ApplicantNeauvia North America
Decision Date2021-07-30
Product CodePBX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Sectum is a medical device manufactured by Neauvia North America. It received FDA 510(k) clearance on 2021-07-30 under approval number K202780. The device is classified under product code PBX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Sectum?
Sectum is a medical device that received FDA 510(k) clearance on 2021-07-30. It is manufactured by Neauvia North America. The 510(k) number is K202780.
When was Sectum approved by the FDA?
Sectum received FDA 510(k) clearance on 2021-07-30, under approval number K202780.
What company makes Sectum?
Sectum is manufactured by Neauvia North America.
What is the FDA product code for Sectum?
The FDA product code for Sectum is PBX.
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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.