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FDA 510(k)

SiOxC Cream

K-Number: K242406 · 2025-03-13

ApplicantSioxmed, LLC
Decision Date2025-03-13
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

SiOxC 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 2025-03-13 under 510(k) number K242406. 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 SiOxC Cream?

SiOxC Cream is a medical device that received FDA 510(k) clearance on 2025-03-13. The listed applicant is Sioxmed, LLC. The 510(k) number is K242406.

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

SiOxC Cream received FDA 510(k) clearance on 2025-03-13, under 510(k) number K242406.

Who is the listed applicant for SiOxC 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 SiOxC Cream?

The FDA product code for SiOxC 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.

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.

Official Source

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