Clearance Summary
PM2+ System and SmartPICC Stylet received FDA 510(k) clearance under submission number K243484, sponsored by Piccolo Medical, Inc.. 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 2025-05-29.
- Submission: K243484
- Applicant / Sponsor: Piccolo Medical, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5970
- Decision date: 2025-05-29
Classification & Regulation
This clearance is catalogued under FDA product code LJS and 21 CFR 880.5970, within the General Hospital review panel as a Class II device.