Clearance Summary
CASTLE SERIES 100 STEAM STERILIZERS (STRAIGHTLINE) received FDA 510(k) clearance under submission number K970907, sponsored by Getinge/Castle, 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 1997-11-12.
- Submission: K970907
- Applicant / Sponsor: Getinge/Castle, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.6880
- Decision date: 1997-11-12
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.