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FDA 510(k)

mcompass Anorectal Balloon Expulsion Catheter (RMD-003-001)

K-Number: K252605 · 2025-12-05

ApplicantMedspira, LLC
Decision Date2025-12-05
Product CodeFFX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

mcompass Anorectal Balloon Expulsion Catheter (RMD-003-001) is the device name listed in this FDA 510(k) record. The listed applicant is Medspira, LLC. It received FDA 510(k) clearance on 2025-12-05 under 510(k) number K252605. The device is classified under product code FFX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the mcompass Anorectal Balloon Expulsion Catheter (RMD-003-001)?

mcompass Anorectal Balloon Expulsion Catheter (RMD-003-001) is a medical device that received FDA 510(k) clearance on 2025-12-05. The listed applicant is Medspira, LLC. The 510(k) number is K252605.

When did mcompass Anorectal Balloon Expulsion Catheter (RMD-003-001) receive FDA 510(k) clearance?

mcompass Anorectal Balloon Expulsion Catheter (RMD-003-001) received FDA 510(k) clearance on 2025-12-05, under 510(k) number K252605.

Who is the listed applicant for mcompass Anorectal Balloon Expulsion Catheter (RMD-003-001)?

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 Balloon Expulsion Catheter (RMD-003-001)?

The FDA product code for mcompass Anorectal Balloon Expulsion Catheter (RMD-003-001) is FFX.

Related Devices (Code: FFX)

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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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