FDA 510(k)

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

K-Nummer: K252605 · 2025-12-05

Entscheidungsdatum2025-12-05

ProduktcodeFFX

BeratungsausschussGU

EntscheidungSubstantially Equivalent

Produktübersicht

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.

Häufig gestellte Fragen

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.

Zugehörige klinische Studien

Zugehörige Einträge werden automatisch anhand von Namen, Produktcodes oder anderen Metadaten abgeglichen. Eine Übereinstimmung begründet kein verifiziertes klinisches, wissenschaftliches, unternehmerisches oder regulatorisches Verhältnis; prüfen Sie die verlinkten offiziellen Quellen.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Verwandte Geräte (Code: FFX)

K240007Solar Compact (G4-1)Laborie Medical Technologies, Corp.K231861EndoflipTM 300 SystemCovidien, LLC K223705EndoflipTM 300Covidien, LLC K222000Transit-PelletsMedifactia AB K201106IntraMarX 3D Radiopaque MarkerAnx Robotica Corp K191087IntraMarX Radiopaque MarkersAnx Robotica Corp

Offizielle Quelle

In der FDA-Datenbank anzeigen →

Daten aus der FDA Open API. Für die aktuellsten und verbindlichen Informationen konsultieren Sie bitte stets den offiziellen Datensatz.