STERLINK FPS-15s Plus sterilizer with STERPACK plus cassette— 510(k) K223015
Substantially EquivalentPlasmapp 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.. Device class: 2.
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
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Daejeon, KR
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More clearances from Plasmapp Co,., Ltd.
view all- K231169 — STERLINK plus Sterilizer with STERLOAD Cassette, Tyvek Roll with CI for STERLINK Sterilizer, Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40)
- K223023 — Terragene Bionava SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40)
- K223025 — Tyvek Roll with CI for STERLINK Sterilizer
- K220345 — STERLINK mini Sterilizer with STERLOAD mini Cassette, Tyvek Roll with CI for STERLINK Sterilizer, Sterilization Process Indicator for STERLINK Sterilizer +1 more
- K212193 — Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40)
Adverse events under product code MLR
product code MLR- Malfunction
- 805
- Total
- 805
Source: openFDA MAUDE database, through . 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.