510(k) K232313

LIGACLIP Endoscopic Rotating Multiple Clip Applier 12mm L (ER420); LIGACLIP Endoscopic Rotating Multiple Clip Applier 10mm M/L (ER320) by Ethicon Endo Surgery, LLC — Product Code FZP

K232313 is an FDA 510(k) premarket notification submitted by Ethicon Endo Surgery, LLC for the device "LIGACLIP Endoscopic Rotating Multiple Clip Applier 12mm L (ER420); LIGACLIP Endoscopic Rotating Multiple Clip Applier 10mm M/L (ER320)". The FDA issued a decision of Substantially Equivalent on August 29, 2023. The device falls under product code FZP (Clip, Implantable), a Class II device regulated under 21 CFR 878.4300. Ethicon Endo Surgery, LLC has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 29, 2023
Date Received
August 2, 2023
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