Clearance Summary
npSIMS Negative Pressure Surgical Incision Management System (npSIMS) received FDA 510(k) clearance under submission number K201400, sponsored by Aatru Medical, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2021-08-23.
- Submission: K201400
- Applicant / Sponsor: Aatru Medical, LLC
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4683
- Decision date: 2021-08-23
Classification & Regulation
This clearance is catalogued under FDA product code QPX and 21 CFR 878.4683, within the General, Plastic Surgery review panel as a Class II device.