Clearance Summary
Reliance® Fusion Sterilization Wraps received FDA 510(k) clearance under submission number K230137, sponsored by Ahlstrom-Munksjo Nonwovens, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2023-12-07.
- Submission: K230137
- Applicant / Sponsor: Ahlstrom-Munksjo Nonwovens, LLC
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.6850
- Decision date: 2023-12-07
Classification & Regulation
This clearance is catalogued under FDA product code FRG and 21 CFR 880.6850, within the General Hospital review panel as a Class II device.