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FDA 510(k)

MCOMPASS ANORECTAL MANOMETRY SYSTEM

K-Number: K120088 · 2012-03-29

ApplicantMedspira, LLC
Decision Date2012-03-29
Product CodeKLA
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MCOMPASS ANORECTAL MANOMETRY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Medspira, LLC. It received FDA 510(k) clearance on 2012-03-29 under 510(k) number K120088. The device is classified under product code KLA. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MCOMPASS ANORECTAL MANOMETRY SYSTEM?

MCOMPASS ANORECTAL MANOMETRY SYSTEM is a medical device that received FDA 510(k) clearance on 2012-03-29. The listed applicant is Medspira, LLC. The 510(k) number is K120088.

When did MCOMPASS ANORECTAL MANOMETRY SYSTEM receive FDA 510(k) clearance?

MCOMPASS ANORECTAL MANOMETRY SYSTEM received FDA 510(k) clearance on 2012-03-29, under 510(k) number K120088.

Who is the listed applicant for MCOMPASS ANORECTAL MANOMETRY SYSTEM?

The FDA 510(k) record lists Medspira, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MCOMPASS ANORECTAL MANOMETRY SYSTEM?

The FDA product code for MCOMPASS ANORECTAL MANOMETRY SYSTEM is KLA.

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Other records listing Medspira, LLC as applicant

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Related Devices (Code: KLA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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