K220345 - 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)
(FDA 510(k) Clearance)

K220345 is an FDA 510(k) clearance for the 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), a Sterilizer, Chemical (Class II — Special Controls, product code MLR), submitted by Plasmapp Co,., Ltd. (Daejeon, KR). The FDA issued a Cleared decision on April 14, 2023, 431 days after receiving the submission on February 7, 2022. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6860.