Fecobionics Anorectal System
FDA 510(k) K242666 · Gi Bionics, LLC
510(k) numberK242666
Submission
- Device name
- Fecobionics Anorectal System
- Applicant
- Gi Bionics, LLC
San Diego, CA, US - Received
- September 5, 2024
- Decision date
- February 12, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KLA – Monitor, Esophageal Motility, Anorectal Motility, And Tube
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1725
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code KLA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K242304 | RedKLA · Traditional | Neuraxis, Inc. | 12/06/2024SE |
| K234107 | Solar Anorectal Manometry Catheter (Model Number: K1210AC-L-2212)KLA · Traditional | Laborie Medical Technologies, Corp. | 04/23/2024SE |
| K180135 | THD Anopress with THD SensyProbeKLA · Traditional | Thd Spa | 03/08/2018SE |
| K161785 | THD AnopressKLA · Traditional | Thd Spa | 03/14/2017SE |
| K143031 | mcompass Biofeedback Anorectal Manometry SystemKLA · Traditional | Medspira, LLC | 07/07/2015SE |
| K120088 | Mcompass Anorectal Manometry SystemKLA · Traditional | Medspira, LLC | 03/29/2012SE |
| K062362 | Single Use Esophageal Manometey Catheters and Single Use Ano-Rectal Manometry CathetersKLA · Traditional | Sarmed Srl | 04/13/2007SE |
| K031617 | Mediplus Single Use Lower Gi Manometry CatheterKLA · Traditional | Mediplus , Ltd. | 01/16/2004SE |
| K032138 | Medtronic Single Use Esophageal Manometric Catheter, Medtronic Single Use Anorectal…KLA · Traditional | Medtronic Vascular | 10/09/2003SE |
| K022023 | Compass Esophageal Pressure Catheter, Model GIE-8500, Compass Ano-Rectal Pressure…KLA · Traditional | Clinical Innovations, Inc. | 01/07/2003SE |
Questions and answers
When was Fecobionics Anorectal System cleared by the FDA?
Fecobionics Anorectal System (K242666) received a 510(k) decision of Substantially Equivalent on February 12, 2025, 160 days after the submission was received.
What is the product code of K242666?
The FDA product code is KLA – Monitor, Esophageal Motility, Anorectal Motility, And Tube, a Class II (moderate risk) device regulated under 21 CFR 876.1725.