Gi Bionics, LLC is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Gi Bionics, LLC - FDA 510(k) Cleared Devices
Recent clearances: Fecobionics Anorectal System
1
Total
1
Cleared
0
Denied
Gi Bionics, LLC has 1 FDA 510(k) cleared medical devices. Based in San Diego, US.
Latest FDA clearance: Feb 2025. Active since 2025. Primary specialty: Gastroenterology & Urology.
Browse the FDA 510(k) cleared devices submitted by Gi Bionics, LLC Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Cygnus Regulatory as regulatory consultant. 1 device has linked clinical trial registered on ClinicalTrials.gov.
FDA 510(k) Regulatory Record - Gi Bionics, LLC
1 devices