Clearance Summary
ULTRASONIC COUPLANT GEL received FDA 510(k) clearance under submission number K854996, sponsored by Johnson & Johnson Professionals, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1986-04-14.
- Submission: K854996
- Applicant / Sponsor: Johnson & Johnson Professionals, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2880
- Decision date: 1986-04-14
Classification & Regulation
This clearance is catalogued under FDA product code JOP and 21 CFR 870.2880, within the Cardiovascular review panel as a Class II device.