Clearance Summary
TISSUEBAG, MODELS: A10 211, A10 212, TBI 100, TBI1011, TBI1021 received FDA 510(k) clearance under submission number K092821, sponsored by Agency For Medical Innovations, 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 2010-02-01.
- Submission: K092821
- Applicant / Sponsor: Agency For Medical Innovations, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2010-02-01
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.