KLA
- 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)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K242666 | 2025-02-12 | Gi Bionics, LLC | Fecobionics Anorectal System | |
| K242304 | 2024-12-06 | Neuraxis, Inc. | RED | |
| K234107 | 2024-04-23 | Laborie Medical Technologies, Corp. | Solar Anorectal Manometry Catheter (Model Number: K… |
Official FDA classification page: KLA
Classification and pathway per current FDA publications. Data from openFDA (CC0).