MEDIPLUS-FOAM AG; MEDIPLUS-COMFORTFOAM AG; MEDIPLUS-SUPERFOAM AG— 510(k) K110062

Clearance details

Applicant

Medipurpose Pte. , Ltd.

Product code

Code FRO

Device class

Unclassified

Advisory panel

Unknown

Date received

2011-01-10

Decision date

2011-09-01

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Alpharetta, GA, US

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Death

30

Injury

653

Malfunction

479

Other

11

Total

1,173

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 →