StatSeal Disc
K-Number: K254073 · 2026-05-13
ApplicantMerit Medical Systems, Inc.
Decision Date2026-05-13
Product CodeFRO
DecisionSubstantially Equivalent
Device Summary
StatSeal Disc is a medical device manufactured by Merit Medical Systems, Inc.. It received FDA 510(k) clearance on 2026-05-13 under approval number K254073. 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 StatSeal Disc?
StatSeal Disc is a medical device that received FDA 510(k) clearance on 2026-05-13. It is manufactured by Merit Medical Systems, Inc.. The 510(k) number is K254073.
When was StatSeal Disc approved by the FDA?
StatSeal Disc received FDA 510(k) clearance on 2026-05-13, under approval number K254073.
What company makes StatSeal Disc?
StatSeal Disc is manufactured by Merit Medical Systems, Inc..
What is the FDA product code for StatSeal Disc?
The FDA product code for StatSeal Disc is FRO. This falls under the Anesthesiology category.
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.