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 a medical device manufactured by Rapid Nexus Nanotech Wound Solutions, Inc.. It received FDA 510(k) clearance on 2025-10-14 under approval 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. It is manufactured by Rapid Nexus Nanotech Wound Solutions, Inc.. The 510(k) number is K250115.

When was Hemastyl() Wound Dressing approved by the FDA?

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

What company makes Hemastyl() Wound Dressing?

Hemastyl() Wound Dressing is manufactured by Rapid Nexus Nanotech Wound Solutions, Inc..

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 Clinical Trials

NCT06420323 NovoX®Cup as Primary Dressing After Breast Reduction ACTIVE_NOT_RECRUITING NCT07607366 Effects of Negative Pressure Wound Bandaging After Mastectomy RECRUITING NCT07409571 Palatal Wound Healing After Free Gingival Graft Surgery RECRUITING NCT07316192 Pelashield™ PainGuard™ vs Restrata® in HS Surgery RECRUITING NCT07600489 A Randomized Non-Inferiority Study of Mepi™ Press 2 vs UrgoK2® for Compression Therapy in Venous Leg Ulcers NOT_YET_RECRUITING NCT07494773 Topical Methylene Blue-Photodynamic Therapy (MB-PDT) for Burn Wound Infection NOT_YET_RECRUITING

Related PubMed Literature

PMID: 40574448 [Research and Discussion on the Whole Lifecycle Supervision of Typical Class Ⅱ Wound Dressing Products]. Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation (2025)

Related Devices (Code: FRO)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.