Clearance Summary
SALUS - Hygiene Instrument Reprocessing Container received FDA 510(k) clearance under submission number K172292, sponsored by Scican , Ltd.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2017-11-24.
- Submission: K172292
- Applicant / Sponsor: Scican , Ltd.
- Clearance pathway: Abbreviated
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.6850
- Decision date: 2017-11-24
Classification & Regulation
This clearance is catalogued under FDA product code KCT and 21 CFR 880.6850, within the General Hospital review panel as a Class II device.