Insufflator
K-Number: K222812 · 2023-05-16
ApplicantScivita Medical Technology Co., Ltd.
Decision Date2023-05-16
Product CodeHIF
Advisory CommitteeOB
DecisionSubstantially Equivalent
Device Summary
Insufflator is a medical device manufactured by Scivita Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-05-16 under approval number K222812. The device is classified under product code HIF. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Insufflator?
Insufflator is a medical device that received FDA 510(k) clearance on 2023-05-16. It is manufactured by Scivita Medical Technology Co., Ltd.. The 510(k) number is K222812.
When was Insufflator approved by the FDA?
Insufflator received FDA 510(k) clearance on 2023-05-16, under approval number K222812.
What company makes Insufflator?
Insufflator is manufactured by Scivita Medical Technology Co., Ltd..
What is the FDA product code for Insufflator?
The FDA product code for Insufflator is HIF.
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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.