Clearance Summary
FLOSHIELD 10MM ENDOSCOPIC CANNULA AND BLUNT OBTURATOR, FLOSHIELD 10MM ENDOSCOPIC CANNULA, FLOSHIELD 10MM BLUNT OBTURATOR received FDA 510(k) clearance under submission number K141272, sponsored by Minimmally Invasive Devices. 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 2014-09-04.
- Submission: K141272
- Applicant / Sponsor: Minimmally Invasive Devices
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2014-09-04
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.