Clearance Summary
CIRCULON SYSTEM STEP 2 received FDA 510(k) clearance under submission number K951021, sponsored by Convatec, A Division of E.R. Squibb & Sons. 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 1995-06-12.
- Submission: K951021
- Applicant / Sponsor: Convatec, A Division of E.R. Squibb & Sons
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5075
- Decision date: 1995-06-12
Classification & Regulation
This clearance is catalogued under FDA product code MCY and 21 CFR 880.5075, within the General Hospital review panel as a Class II device.