510(k) K062850

AUTOSUTURE CIRCULAR EEA SURGICAL STAPLERS by United States Surgical, A Division of Tyco Healthc — Product Code GDW

K062850 is an FDA 510(k) premarket notification submitted by United States Surgical, A Division of Tyco Healthc for the device "AUTOSUTURE CIRCULAR EEA SURGICAL STAPLERS". The FDA issued a decision of Substantially Equivalent on October 23, 2006. The device falls under product code GDW (Staple, Implantable), a Class II device regulated under 21 CFR 878.4750. United States Surgical, A Division of Tyco Healthc has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 23, 2006
Date Received
September 25, 2006
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Staple, Implantable
Device Class
Class II
Regulation Number
878.4750
Review Panel
SU
Submission Type