KLA

Monitor, Esophageal Motility, Anorectal Motility, And Tube

Product code
KLA
Device name
Monitor, Esophageal Motility, Anorectal Motility, And Tube
Device class
Class 2
21 CFR
21 CFR 876.1725
Medical specialty
Gastroenterology, Urology
Marketing pathway
510(K)
Flag
Third-party review eligible
510(k) clearances (last 3 years)
3
Summaries archived here
3 (direct download)
510(k) clearances (all years, FDA)
31 (all years; only the last 3 years are listed here)

510(k) clearances, last 3 years (3)

Last three years. Most recent: 2025-02-12.

NumberDecision dateApplicantDevice nameSummary
K2426662025-02-12Gi Bionics, LLCFecobionics Anorectal SystemPDF
K2423042024-12-06Neuraxis, Inc.REDPDF
K2341072024-04-23Laborie Medical Technologies, Corp.Solar™ Anorectal Manometry Catheter (Model Number: K…PDF

3 summaries are archived here for direct download.

Official FDA classification page: KLA
Classification and pathway per current FDA publications. Data from openFDA (CC0).