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FDA 510(k)

Hemastyl(™) Wound Dressing

K-Number: K250115 · 2025-10-14

ApplicantRapid Nexus Nanotech Wound Solutions, Inc.
Decision Date2025-10-14
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

Hemastyl(™) Wound Dressing is the device name listed in this FDA 510(k) record. The listed applicant is Rapid Nexus Nanotech Wound Solutions, Inc.. It received FDA 510(k) clearance on 2025-10-14 under 510(k) number K250115. 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 Hemastyl(™) Wound Dressing?

Hemastyl(™) Wound Dressing is a medical device that received FDA 510(k) clearance on 2025-10-14. The listed applicant is Rapid Nexus Nanotech Wound Solutions, Inc.. The 510(k) number is K250115.

When did Hemastyl(™) Wound Dressing receive FDA 510(k) clearance?

Hemastyl(™) Wound Dressing received FDA 510(k) clearance on 2025-10-14, under 510(k) number K250115.

Who is the listed applicant for Hemastyl(™) Wound Dressing?

The FDA 510(k) record lists Rapid Nexus Nanotech Wound Solutions, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Hemastyl(™) Wound Dressing?

The FDA product code for Hemastyl(™) Wound Dressing is FRO. This falls under the Anesthesiology category.

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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