STERLINKTM FPS-15s Plus Sterilizer with STERLOADTM Cassette— 510(k) K212200

Clearance details

Applicant

Plasmapp Co,., Ltd.

Product code

Code MLR

Device class

Class 2

Regulation

21 CFR 880.6860

Advisory panel

General Hospital

Date received

2021-07-14

Decision date

2021-10-22

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Daejeon, KR

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Malfunction

805

Total

805

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 →