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FDA 510(k)

SBC1 Cream

K-Number: K250890 · 2026-01-12

ApplicantSioxmed, LLC
Decision Date2026-01-12
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

SBC1 Cream is a medical device manufactured by Sioxmed, LLC. It received FDA 510(k) clearance on 2026-01-12 under approval number K250890. 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 SBC1 Cream?

SBC1 Cream is a medical device that received FDA 510(k) clearance on 2026-01-12. It is manufactured by Sioxmed, LLC. The 510(k) number is K250890.

When was SBC1 Cream approved by the FDA?

SBC1 Cream received FDA 510(k) clearance on 2026-01-12, under approval number K250890.

What company makes SBC1 Cream?

SBC1 Cream is manufactured by Sioxmed, LLC.

What is the FDA product code for SBC1 Cream?

The FDA product code for SBC1 Cream is FRO. This falls under the Anesthesiology category.

Other Devices by Sioxmed, LLC

Related Devices (Code: FRO)

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.