Clearance Summary
Hemastyl() Wound Dressing received FDA 510(k) clearance under submission number K250115, sponsored by Rapid Nexus Nanotech Wound Solutions, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Unknown review panel. The statutory decision date of record is 2025-10-14.
- Submission: K250115
- Applicant / Sponsor: Rapid Nexus Nanotech Wound Solutions, Inc.
- Clearance pathway: Traditional
- Review panel: Unknown
- Device class:
- Decision date: 2025-10-14
Classification & Regulation
This clearance is catalogued under FDA product code FRO , within the Unknown review panel as a device.