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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 the device name listed in this FDA 510(k) record. The listed applicant is Sioxmed, LLC. It received FDA 510(k) clearance on 2026-01-12 under 510(k) 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. The listed applicant is Sioxmed, LLC. The 510(k) number is K250890.

When did SBC1 Cream receive FDA 510(k) clearance?

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

Who is the listed applicant for SBC1 Cream?

The FDA 510(k) record lists Sioxmed, LLC as the applicant. This does not by itself establish the device manufacturer.

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 records listing Sioxmed, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K242406SiOxC CreamK241660SiOxD® Wound MatrixK232847SiOxD Wound MatrixK222189SiOxD Wound Matrix

Related Devices (Code: FRO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261646Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.K253665Vashe Plus Antimicrobial SolutionUrgo Medical North America, LLCK261023Microdacyn Wound Irrigation SolutionSonoma Pharmaceuticals, Inc.K251929SilverCeuticals® Antimicrobial Wound GelSilverceuticals, Inc.K261638Bonvadis®Oneness Biotech Co., Ltd.K254073StatSeal DiscMerit Medical Systems, Inc.

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.

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