mcompass Anorectal Balloon Expulsion Catheter (RMD-003-001)
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K252605 FDA 510(k)
- FDA Product Code
- FFX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.1725 FDA 510(k)
- Regulation Number
- 876.1725 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The mcompass Anorectal Balloon Expulsion Catheter (RMD-003-001) is a system for gastrointestinal motility testing, specifically designed for anorectal manometry applications. It is used to perform a Balloon Expulsion Test (BET) to assess pelvic floor function and rectal sensation.
The device is a single-use, non-sterile, disposable catheter approximately 60 cm in length. It is supplied as a finished device and is regulated under FDA 510(k) clearance with product code FFX and regulation number 876.1725, classified as a Class II device for gastroenterology and urology use.
Frequently asked questions
What is the mcompass Anorectal Balloon Expulsion Catheter used for?
The mcompass Anorectal Balloon Expulsion Catheter (RMD-003-001) is used to perform a Balloon Expulsion Test (BET) as part of gastrointestinal motility testing, specifically for anorectal manometry applications to assess pelvic floor function and rectal sensation.
Is the mcompass Anorectal Balloon Expulsion Catheter sterile or non-sterile, and is it reusable?
The device is supplied as a non-sterile, single-use, disposable catheter and is not intended for reuse; it is designed for one-time patient use only to ensure safety and prevent cross-contamination.
What are the physical characteristics and supply format of the mcompass Anorectal Balloon Expulsion Catheter?
The catheter is approximately 60 cm in length and is supplied as a finished device, ready for immediate use in clinical settings for anorectal manometry procedures.
How is the mcompass Anorectal Balloon Expulsion Catheter regulated, and what is its classification?
The device is regulated under FDA 510(k) clearance with product code FFX and regulation number 876.1725, and is classified as a Class II device for gastroenterology and urology use.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Medspira | Home, mcompass Anorectal Catheter | Medical Device Navigator, Medspira | mcompass® - Anorectal Manometry and Manometric Biofeedback…, mcompass Anorectal Balloon Expulsion Catheter (RMD-003-001)
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K252605 | Class II | Active |
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Manufacturer
- Manufacturer
- Medspira, Llc
Sources (1)
- FDA 510(k) K252605 24 fields · synced Sep 28, 2026