LUPINE LOOP— 510(k) K050771

Clearance details

Applicant

Depuy Mitek, A Johnson & Johnson Company

Product code

Code GAM

Device class

Class 2

Regulation

21 CFR 878.4493

Advisory panel

General, Plastic Surgery

Date received

2005-03-25

Decision date

2005-04-08

Decision

Substantially Equivalent

Clearance type

Special

Location

Norwood, MA, US

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Death

45

Injury

5,711

Malfunction

30,744

Other

4

Total

36,504

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 →