Clearance Summary
Tuttnauer Pre-vacuum Steam Sterilizer models 3870HSG and 3870HSG-WS received FDA 510(k) clearance under submission number K222608, sponsored by Tuttnauer , Ltd.. 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 2022-12-16.
- Submission: K222608
- Applicant / Sponsor: Tuttnauer , Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.6880
- Decision date: 2022-12-16
Classification & Regulation
This clearance is catalogued under FDA product code FLE and 21 CFR 880.6880, within the General Hospital review panel as a Class II device.