Clearance Summary
RETRIEVAL BAG received FDA 510(k) clearance under submission number K123728, sponsored by Flexbar Machine Corp.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2013-12-11.
- Submission: K123728
- Applicant / Sponsor: Flexbar Machine Corp.
- Clearance pathway: Abbreviated
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2013-12-11
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.