Clearance Summary
COMFORT SHEATH REUSABLE MALE EXTERNAL CATHETER received FDA 510(k) clearance under submission number K962384, sponsored by Sierra Laboratories, 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 1996-07-15.
- Submission: K962384
- Applicant / Sponsor: Sierra Laboratories, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class I
- Regulation citation: 21 CFR 876.5250
- Decision date: 1996-07-15
Classification & Regulation
This clearance is catalogued under FDA product code EXJ and 21 CFR 876.5250, within the Gastroenterology, Urology review panel as a Class I device.