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.

Clearance details

Applicant: Gi Bionics, LLC
Product code: Code KLA
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

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