Fecobionics Anorectal System— 510(k) K242666

Substantially Equivalent

Gi Bionics, LLC

FDA 510(k) clearance K242666 for Fecobionics Anorectal System, Substantially Equivalent on 2025-02-12. Applicant: Gi Bionics, LLC. Device class: 2.

Clearance details

Applicant: Gi Bionics, LLC
Product code: Code KLA
Device class: Class 2
Regulation: 21 CFR 876.1725
Advisory panel: Gastroenterology, Urology
Date received: 2024-09-05
Decision date: 2025-02-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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K234107 — Solar Anorectal Manometry Catheter (Model Number: K1210AC-L-2212)2024-04-23
K180135 — THD Anopress with THD SensyProbe2018-03-08
K161785 — THD ANOPRESS2017-03-14
K143031 — mcompass Biofeedback Anorectal Manometry System2015-07-07

Data sourced from openFDA. This site is unofficial and independent of the FDA.