Clearance Summary
gke Steri-Record Steam Mini-Bio-Plus self-contained biological indicator (SCBI) received FDA 510(k) clearance under submission number K163144, sponsored by Gke-GmbH. 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 2017-04-07.
- Submission: K163144
- Applicant / Sponsor: Gke-GmbH
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.2800
- Decision date: 2017-04-07
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.