Clearance Summary
BUSSE UMBILICAL CORD CLAMP CUTTER received FDA 510(k) clearance under submission number K021055, sponsored by Busse Hospital Disposables, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 2002-04-29.
- Submission: K021055
- Applicant / Sponsor: Busse Hospital Disposables, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4530
- Decision date: 2002-04-29
Classification & Regulation
This clearance is catalogued under FDA product code HFW and 21 CFR 884.4530, within the Obstetrics/Gynecology review panel as a Class II device.