Intact Medical Corporation is one of 15057 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
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
Intact Medical Corporation has 4 FDA 510(k) cleared medical devices. Based in Natick, US.
Historical record: 4 cleared submissions from 2006 to 2016. Primary specialty: Gastroenterology & Urology.
Browse the FDA 510(k) cleared devices submitted by Intact Medical Corporation Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Hogan Lovells US LLP as regulatory consultant. 1 device has linked clinical trial registered on ClinicalTrials.gov.
FDA 510(k) Regulatory Record - Intact Medical Corporation
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