510(k) K050344

LIGACLIP 5 M/L MM ENDOSCOPIC MULTIPLE CLIP APPLIER by Ethicon Endo Surgery, Inc. — Product Code FZP

K050344 is an FDA 510(k) premarket notification submitted by Ethicon Endo Surgery, Inc. for the device "LIGACLIP 5 M/L MM ENDOSCOPIC MULTIPLE CLIP APPLIER". The FDA issued a decision of Substantially Equivalent on March 14, 2005. The device falls under product code FZP (Clip, Implantable), a Class II device regulated under 21 CFR 878.4300. Ethicon Endo Surgery, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 14, 2005
Date Received
February 11, 2005
Clearance Type
Traditional
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