Clearance Summary
PMSSteripack Flat Sterilization Pouch (FP) and Roll (FL) with Chemical Indicator received FDA 510(k) clearance under submission number K162362, sponsored by Pms Tibbi Cihazlar Teknolojisi San VE Tic AS. 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 2017-10-13.
- Submission: K162362
- Applicant / Sponsor: Pms Tibbi Cihazlar Teknolojisi San VE Tic AS
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.6850
- Decision date: 2017-10-13
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.