SBC1 Cream

FDA 510(k) K250890 · Sioxmed, LLC

Substantially Equivalent

510(k) numberK250890

Submission

Device name
SBC1 Cream
Applicant
Sioxmed, LLC
Winston Salem, NC, US
Received
March 25, 2025
Decision date
January 12, 2026
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
FRO – Dressing, Wound, Drug
Device class
Unclassified

Other 510(k)s with product code FRO

510(k)DeviceApplicantDecision
K254041SkinSmart Antimicrobial HydroGelFRO · Traditional Magic Science Supply, LLC09/11/2026SE
K261646Redermax® Antibacterial Wound MatrixFRO · Traditional Beijing Kreate Medical Co., Ltd.08/14/2026SE
K253665Vashe Plus Antimicrobial SolutionFRO · Traditional Urgo Medical North America, LLC08/11/2026SE
K261023Microdacyn Wound Irrigation SolutionFRO · Traditional Sonoma Pharmaceuticals, Inc.06/24/2026SE
K251929SilverCeuticals® Antimicrobial Wound GelFRO · Traditional Silverceuticals, Inc.06/24/2026SE
K261638Bonvadis®FRO · Special Oneness Biotech Co., Ltd.06/17/2026SE
K254073StatSeal DiscFRO · Traditional Merit Medical Systems, Inc.05/13/2026SE
K254191IWD-Gel™FRO · Traditional InnovaCorium, Inc.04/07/2026SE
K252023MiraChlor Antimicrobial Wound SolutionFRO · Traditional Letus Corporation03/25/2026SE
K251999Promogran Prisma™ Collagen Matrix with ORC and SilverFRO · Traditional Solventum Germany GmbH03/13/2026SE

More from Solventum Germany GmbH

510(k)DeviceDecision
K242406SiOxC CreamFRO · Traditional 03/13/2025SE
K241660SiOxD® Wound MatrixQSZ · Special 07/05/2024SE
K232847SiOxD Wound MatrixQSZ · Traditional 12/18/2023SE
K222189SiOxD Wound MatrixQSZ · Traditional 11/18/2022SE

Questions and answers

When was SBC1 Cream cleared by the FDA?

SBC1 Cream (K250890) received a 510(k) decision of Substantially Equivalent on January 12, 2026, 293 days after the submission was received.

What is the product code of K250890?

The FDA product code is FRO – Dressing, Wound, Drug, a Unclassified device.