IWD-Gel
K-Number: K254191 · 2026-04-07
ApplicantInnovaCorium, Inc.
Decision Date2026-04-07
Product CodeFRO
DecisionSubstantially Equivalent
Device Summary
IWD-Gel is a medical device manufactured by InnovaCorium, Inc.. It received FDA 510(k) clearance on 2026-04-07 under approval number K254191. The device is classified under product code FRO. Product code FRO falls under the category of Anesthesiology, which includes devices for anesthetic delivery and patient monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the IWD-Gel?
IWD-Gel is a medical device that received FDA 510(k) clearance on 2026-04-07. It is manufactured by InnovaCorium, Inc.. The 510(k) number is K254191.
When was IWD-Gel approved by the FDA?
IWD-Gel received FDA 510(k) clearance on 2026-04-07, under approval number K254191.
What company makes IWD-Gel?
IWD-Gel is manufactured by InnovaCorium, Inc..
What is the FDA product code for IWD-Gel?
The FDA product code for IWD-Gel is FRO. This falls under the Anesthesiology category.
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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.