Intact Medical Corporation - FDA 510(k) Cleared Devices
Recent clearances: Intact® Gen2 System, Intact Advance and Intact Excision XL, Intact BLES, INTACT BREAST LESION EXCISION SYSTEM WITH INTACT EXCISION XL
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Intact Medical Corporation Gastroenterology & Urology ✕
4 devices
Cleared
Feb 15, 2016
Intact® Gen2 System
Gastroenterology & Urology
158d
Cleared
CT
Dec 15, 2014
Intact Advance and Intact Excision XL, Intact BLES
Gastroenterology & Urology
103d
Cleared
Jun 17, 2008
INTACT BREAST LESION EXCISION SYSTEM WITH INTACT EXCISION XL
Gastroenterology & Urology
64d
Cleared
Apr 27, 2006
INTACT BREAST LESION EXCISION SYSTEM AND ADVANCE
Gastroenterology & Urology
70d