Clearance Summary
ADAM (ABSORBENT INCONTINENCE SHIELD) received FDA 510(k) clearance under submission number K854729, sponsored by Lic-Orthion. 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 1986-02-06.
- Submission: K854729
- Applicant / Sponsor: Lic-Orthion
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class I
- Regulation citation: 21 CFR 876.5920
- Decision date: 1986-02-06
Classification & Regulation
This clearance is catalogued under FDA product code EYQ and 21 CFR 876.5920, within the Gastroenterology, Urology review panel as a Class I device.