Instylla Delivery Kit
K-Number: K253769 · 2025-12-22
ApplicantInstylla, Inc.
Decision Date2025-12-22
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
Instylla Delivery Kit is a medical device manufactured by Instylla, Inc.. It received FDA 510(k) clearance on 2025-12-22 under approval number K253769. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Instylla Delivery Kit?
Instylla Delivery Kit is a medical device that received FDA 510(k) clearance on 2025-12-22. It is manufactured by Instylla, Inc.. The 510(k) number is K253769.
When was Instylla Delivery Kit approved by the FDA?
Instylla Delivery Kit received FDA 510(k) clearance on 2025-12-22, under approval number K253769.
What company makes Instylla Delivery Kit?
Instylla Delivery Kit is manufactured by Instylla, Inc..
What is the FDA product code for Instylla Delivery Kit?
The FDA product code for Instylla Delivery Kit is FMF.
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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.