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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 a medical device manufactured by Medspira, LLC. It received FDA 510(k) clearance on 2025-12-05 under approval 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. It is manufactured by Medspira, LLC. The 510(k) number is K252605.

When was mcompass Anorectal Balloon Expulsion Catheter (RMD-003-001) approved by the FDA?

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

What company makes mcompass Anorectal Balloon Expulsion Catheter (RMD-003-001)?

mcompass Anorectal Balloon Expulsion Catheter (RMD-003-001) is manufactured by Medspira, LLC.

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.

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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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