Mcompass Anorectal Manometry System

FDA 510(k) K120088 · Medspira, LLC

Substantially Equivalent

510(k) numberK120088

Submission

Device name
Mcompass Anorectal Manometry System
Applicant
Medspira, LLC
Minneapolis, MN, US
Received
January 11, 2012
Decision date
March 29, 2012
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA
Third-party review
Yes

Official FDA 510(k) record

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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More from Clinical Innovations, Inc.

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Questions and answers

When was Mcompass Anorectal Manometry System cleared by the FDA?

Mcompass Anorectal Manometry System (K120088) received a 510(k) decision of Substantially Equivalent on March 29, 2012, 78 days after the submission was received.

What is the product code of K120088?

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.