K242666
- 510(k) number
- K242666
- Device name
- Fecobionics Anorectal System
- Applicant
- Gi Bionics, LLC CA · US
- Product code
- KLA — Monitor, Esophageal Motility, Anorectal Motility, An
- Decision date
- 2025-02-12
- Date received
- 2024-09-05
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K242666.pdf
Official FDA record: K242666
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.