Medical Device Manufacturer · US , Ayer , MA

Spirus Medical, Inc. - FDA 510(k) Cleared Devices

5 submissions · 5 cleared · Since 2005

Recent clearances: SPIRUS MEDICAL ENDO-EASE ENDOSCOPIC OVERTUBE, SPIRUS MEDICAL SURGICAL INSTRUMENT, MODIFICATION TO ENDO-EASE

5

Total

5

Cleared

0

Denied

FDA 510(k) Regulatory Record - Spirus Medical, Inc. Gastroenterology & Urology ✕

4 devices

1-4 of 4

Cleared May 06, 2008

SPIRUS MEDICAL ENDO-EASE ENDOSCOPIC OVERTUBE

Gastroenterology & Urology · 119d

Cleared Oct 13, 2006

MODIFICATION TO ENDO-EASE

Gastroenterology & Urology · 24d

Cleared Aug 04, 2006

ENDO-EASE ENDOSCOPIC OVERTUBE

Gastroenterology & Urology · 186d

Cleared Sep 14, 2005

ENDO-EASE ENDOSCOPIC OVERTUBE

Gastroenterology & Urology · 43d