Clearance Summary
HENKE SASS WOLF OF AMERICA BARIATRIC LAPAROSCOPE received FDA 510(k) clearance under submission number K050163, sponsored by Henke Sass Wolf of America, 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 2005-03-24.
- Submission: K050163
- Applicant / Sponsor: Henke Sass Wolf of America, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2005-03-24
Classification & Regulation
This clearance is catalogued under FDA product code GCJ and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.