Clearance Summary
MEDCOMP BIO-FLEX CS CATHETER (CS100) received FDA 510(k) clearance under submission number K971925, sponsored by Medical Components, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 1998-02-23.
- Submission: K971925
- Applicant / Sponsor: Medical Components, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5540
- Decision date: 1998-02-23
Classification & Regulation
This clearance is catalogued under FDA product code MSD and 21 CFR 876.5540, within the Gastroenterology, Urology review panel as a Class II device.