MENTOR PERCUTANEOUS MALECOT NEPHROSTOMY SET— 510(k) K850287

Clearance details

Applicant

Mentor Corp.

Product code

Code LJE

Device class

Unclassified

Advisory panel

Unknown

Date received

1985-01-24

Decision date

1985-03-07

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Goleta, CA, US

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Death

6

Total

6

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 →