510(k) K061288

AUTO SUTURE ENDO CLIP III 5 MM CLIP APPLIER by United States Surgical, A Division of Tyco Healthc — Product Code FZP

K061288 is an FDA 510(k) premarket notification submitted by United States Surgical, A Division of Tyco Healthc for the device "AUTO SUTURE ENDO CLIP III 5 MM CLIP APPLIER". The FDA issued a decision of Substantially Equivalent on November 2, 2006. The device falls under product code FZP (Clip, Implantable), a Class II device regulated under 21 CFR 878.4300. 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
November 2, 2006
Date Received
May 9, 2006
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Clip, Implantable
Device Class
Class II
Regulation Number
878.4300
Review Panel
SU
Submission Type