Medspira, LLC is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Medspira, LLC - FDA 510(k) Cleared Devices
Recent clearances: mcompass Anorectal Balloon Expulsion Catheter (RMD-003-001)
3
Total
3
Cleared
0
Denied
Medspira, LLC has 3 FDA 510(k) cleared medical devices. Based in Minneapolis, US.
Latest FDA clearance: Dec 2025. Active since 2012. Primary specialty: Gastroenterology & Urology.
Browse the FDA 510(k) cleared devices submitted by Medspira, LLC Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Bluebird Consulting, LLC as regulatory consultant.
FDA 510(k) Regulatory Record - Medspira, LLC
3 devices
Cleared
Dec 05, 2025
mcompass Anorectal Balloon Expulsion Catheter (RMD-003-001)
Gastroenterology & Urology
109d
Cleared
Jul 07, 2015
mcompass Biofeedback Anorectal Manometry System
Gastroenterology & Urology
259d
Cleared
Mar 29, 2012
MCOMPASS ANORECTAL MANOMETRY SYSTEM
Gastroenterology & Urology
78d