Plasmapp Co,., Ltd.

Plasmapp Co,., Ltd. has submitted 8 FDA 510(k) premarket notifications since 2021, of which 8 received clearance as substantially equivalent to a predicate device.

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)

K231169 · MLR Sterilizer, Chemical · General Hospital

May 2023 30d

STERLINK? FPS-15s Plus sterilizer with STERPACK? plus cassette

K223015 · MLR Sterilizer, Chemical · General Hospital

May 2023 222d

Terragene Bionava SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40)

K223023 · FRC Indicator, Biological... · General Hospital

May 2023 222d

Tyvek Roll with CI for STERLINK Sterilizer

K223025 · FRG Wrap, Sterilization · General Hospital

May 2023 222d

STERLINK mini Sterilizer with STERLOAD mini Cassette, Tyvek Roll with CI for STERLINK Sterilizer, Sterilization Process Indicator for STERLINK Sterilizer; Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-Bio), Terragene Chemdye (CD42), Terragene Cintape (CT40)

K220345 · MLR Sterilizer, Chemical · General Hospital

Apr 2023 431d

Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40)

K212193 · FRC Indicator, Biological... · General Hospital

Oct 2021 100d

Tyvek(R) Roll with CI for STERLINKTM Sterilizer

K212198 · FRG Wrap, Sterilization · General Hospital

Oct 2021 100d

STERLINKTM FPS-15s Plus Sterilizer with STERLOADTM Cassette

K212200 · MLR Sterilizer, Chemical · General Hospital

Oct 2021 100d

Plasmapp Co,., Ltd. — FDA 510(k) Submissions

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