Clearance Summary
STERIZONE VP4 Test Pack received FDA 510(k) clearance under submission number K203560, sponsored by Tso3 Inc., Now A Part of Stryker. 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 2021-03-24.
- Submission: K203560
- Applicant / Sponsor: Tso3 Inc., Now A Part of Stryker
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.2800
- Decision date: 2021-03-24
Classification & Regulation
This clearance is catalogued under FDA product code FRC and 21 CFR 880.2800, within the General Hospital review panel as a Class II device.