Clearance Summary
RIZA BAND STRETCHER (RBS)-60000 received FDA 510(k) clearance under submission number K001236, sponsored by R-Med, 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 2000-07-17.
- Submission: K001236
- Applicant / Sponsor: R-Med, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.4400
- Decision date: 2000-07-17
Classification & Regulation
This clearance is catalogued under FDA product code FHN and 21 CFR 876.4400, within the Gastroenterology, Urology review panel as a Class II device.