mcompass Biofeedback Anorectal Manometry System
FDA 510(k) K143031 · Medspira, LLC
510(k) numberK143031
Submission
- Device name
- mcompass Biofeedback Anorectal Manometry System
- Applicant
- Medspira, LLC
Minneapolis, MN, US - Received
- October 21, 2014
- Decision date
- July 7, 2015
- 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
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| 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 |
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Questions and answers
When was mcompass Biofeedback Anorectal Manometry System cleared by the FDA?
mcompass Biofeedback Anorectal Manometry System (K143031) received a 510(k) decision of Substantially Equivalent on July 7, 2015, 259 days after the submission was received.
What is the product code of K143031?
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.