510(k) K061276

G-PROX ENDOSCOPIC GRASPER by Usgi Medical — Product Code GAT

K061276 is an FDA 510(k) premarket notification submitted by Usgi Medical for the device "G-PROX ENDOSCOPIC GRASPER". The FDA issued a decision of Substantially Equivalent on December 6, 2006. The device falls under product code GAT (Suture, Nonabsorbable, Synthetic, Polyethylene), a Class II device regulated under 21 CFR 878.5000. Usgi Medical has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 6, 2006
Date Received
May 8, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Suture, Nonabsorbable, Synthetic, Polyethylene
Device Class
Class II
Regulation Number
878.5000
Review Panel
SU
Submission Type