LIGACLIP Endoscopic Rotating Multiple Clip Applier 12mm L (ER420) +1 more— 510(k) K232313

Clearance details

Device name as filed

LIGACLIP Endoscopic Rotating Multiple Clip Applier 12mm L (ER420); LIGACLIP Endoscopic Rotating Multiple Clip Applier 10mm M/L (ER320)

Applicant

Ethicon Endo Surgery, LLC

Product code

Code FZP

Device class

Class 2

Regulation

21 CFR 878.4300

Advisory panel

General, Plastic Surgery

Date received

2023-08-02

Decision date

2023-08-29

Decision

Substantially Equivalent

Clearance type

Special

Location

Guaynabo, PR

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Death

11

Injury

726

Malfunction

10,830

Other

1

Total

11,568

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →