STERLINK FPS-15s Plus sterilizer with STERPACK plus cassette— 510(k) K223015

Substantially Equivalent

Plasmapp Co,., Ltd.

FDA 510(k) clearance K223015 for STERLINK FPS-15s Plus sterilizer with STERPACK plus cassette, Substantially Equivalent on 2023-05-09. Applicant: Plasmapp Co,., Ltd..

Clearance details

Applicant: Plasmapp Co,., Ltd.
Product code: Code MLR
Advisory panel: General Hospital
Date received: 2022-09-29
Decision date: 2023-05-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Daejeon, KR

Download summary PDF View on FDA.gov ↗

Adverse events under product code MLR

product code MLR

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 →

Data sourced from openFDA. This site is unofficial and independent of the FDA.