Clearance Summary
Anprolene AN75 Ethylene Oxide Gas Sterilizer received FDA 510(k) clearance under submission number K170432, sponsored by Andersen Sterilizers, Inc.. 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 2017-10-31.
- Submission: K170432
- Applicant / Sponsor: Andersen Sterilizers, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.6860
- Decision date: 2017-10-31
Classification & Regulation
This clearance is catalogued under FDA product code FLF and 21 CFR 880.6860, within the General Hospital review panel as a Class II device.