FDA 510(k)

SBC1 製劑

K 號：K250890 · 2026-01-12

決定日期2026-01-12

產品代碼FRO

決定相當於

器材摘要

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.

常見問題

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.

其他以 Sioxmed, LLC 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K242406SiOxC膚膏 K241660SiOxD® 瘘管組織 K232847SiOxD 瘘傷組織 K222189SiOxD 瘘傷組織

相關器械（代碼：FRO）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K254168Actolind® (06.3637. Actolind®膠漿)ACTO GmbH K254041皮膚智選抗菌濕凝膠Magic Science Supply, LLC K261646Redermax® 抗菌傷口組織Beijing Kreate Medical Co., Ltd.K253665Vashe Plus 抗菌溶液Urgo Medical North America, LLC K251929SilverCeuticals® 抗菌傷口膠Silverceuticals, Inc.K261023微達辛傷口灌洗溶液Sonoma Pharmaceuticals, Inc.

官方來源

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