IWD-Gel™
K号: K254191 · 2026-04-07
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器械摘要
IWD-Gel™ is the device name listed in this FDA 510(k) record. The listed applicant is InnovaCorium, Inc.. It received FDA 510(k) clearance on 2026-04-07 under 510(k) 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.
常见问题
What is the IWD-Gel™?
IWD-Gel™ is a medical device that received FDA 510(k) clearance on 2026-04-07. The listed applicant is InnovaCorium, Inc.. The 510(k) number is K254191.
When did IWD-Gel™ receive FDA 510(k) clearance?
IWD-Gel™ received FDA 510(k) clearance on 2026-04-07, under 510(k) number K254191.
Who is the listed applicant for IWD-Gel™?
The FDA 510(k) record lists InnovaCorium, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for IWD-Gel™?
The FDA product code for IWD-Gel™ is FRO. This falls under the Anesthesiology category.
相关器械（代码：FRO）
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官方来源
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