Clearance Summary
DACOMED EXTERNAL MALE CONTINENCE DEVICE received FDA 510(k) clearance under submission number K885323, sponsored by Dacomed Corp.. 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 1989-02-08.
- Submission: K885323
- Applicant / Sponsor: Dacomed Corp.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class I
- Regulation citation: 21 CFR 876.5160
- Decision date: 1989-02-08
Classification & Regulation
This clearance is catalogued under FDA product code FHA and 21 CFR 876.5160, within the Gastroenterology, Urology review panel as a Class I device.