Glustitch, Inc. is one of 571 FDA 510(k) medical device manufacturers from Canada in the dataset, ranked by real submission volume.
Glustitch, Inc. - FDA 510(k) Cleared Devices
Recent clearances: GluStitch Twist Tissue Adhesive, GLUSEAL 90, MODEL GLU9010, PERIACRYL 90,80,70,60, MODEL9010, 8020, 7030, 6040
5
Total
5
Cleared
0
Denied
Glustitch, Inc. has 5 FDA 510(k) cleared medical devices. Based in Delta, CA.
Historical record: 5 cleared submissions from 2001 to 2016. Primary specialty: General & Plastic Surgery.
Browse the FDA 510(k) cleared devices submitted by Glustitch, Inc. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Regulatory and Clinical Research Institute, Inc. as regulatory consultant.
FDA 510(k) Regulatory Record - Glustitch, Inc.
5 devices
Cleared
Jan 14, 2016
GluStitch Twist Tissue Adhesive
General & Plastic Surgery
371d
Cleared
Feb 23, 2009
GLUSEAL 90, MODEL GLU9010
General & Plastic Surgery
68d
Cleared
Oct 10, 2007
PERIACRYL 90,80,70,60, MODEL9010, 8020, 7030, 6040
Dental
133d
Cleared
Aug 21, 2003
GLUSEAL 5ML DISPENSER, 1 ML DISPENSER, .2 ML DISPENSER
General & Plastic Surgery
178d
Cleared
Dec 20, 2001
GLUSITE, MODEL GLU002
Dental
64d