Clearance Summary
ENDOGATER AVANTAGE CO2 INSUFFLATOR received FDA 510(k) clearance under submission number K113310, sponsored by Byrne Medical, 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 2012-06-20.
- Submission: K113310
- Applicant / Sponsor: Byrne Medical, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2012-06-20
Classification & Regulation
This clearance is catalogued under FDA product code FCX and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.