mcompass Biofeedback Anorectal Manometry System— 510(k) K143031

Name: FDA 510(k) clearance K143031
Creator: U.S. Food and Drug Administration
Published: 2015-07-07

Substantially Equivalent

Medspira, LLC

FDA 510(k) clearance K143031 for mcompass Biofeedback Anorectal Manometry System, Substantially Equivalent on 2015-07-07. Applicant: Medspira, LLC. Device class: 2.

Clearance details

Applicant: Medspira, LLC
Product code: Code KLA
Device class: Class 2
Regulation: 21 CFR 876.1725
Advisory panel: Gastroenterology, Urology
Date received: 2014-10-21
Decision date: 2015-07-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K143031

K-number listed on FDA's recall record

Z-3072-2017 — mcompass 2-channel Balloon Catheters The mcompass Biofeedback Anorectal Manometry System is for use on patients requiring anorectal pressure studies. mcompass Anorectal Manometry System (RMD-001-001) which includes a FOB component connected to the balloon catheter to inflate and deflate and a medical grade tablet PC to run the software. The software is not included in the recall, only the balloon catheter component.Class II·Terminated·Medspira, Llc·20170614

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K143031.

Data sourced from openFDA. This site is unofficial and independent of the FDA.