STERLINK FPS-15s Plus sterilizer with STERPACK plus cassette
K-Number: K223015 · 2023-05-09
ApplicantPlasmapp Co,., Ltd.
Decision Date2023-05-09
Product CodeMLR
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
STERLINK FPS-15s Plus sterilizer with STERPACK plus cassette is a medical device manufactured by Plasmapp Co,., Ltd.. It received FDA 510(k) clearance on 2023-05-09 under approval number K223015. The device is classified under product code MLR. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the STERLINK FPS-15s Plus sterilizer with STERPACK plus cassette?
STERLINK FPS-15s Plus sterilizer with STERPACK plus cassette is a medical device that received FDA 510(k) clearance on 2023-05-09. It is manufactured by Plasmapp Co,., Ltd.. The 510(k) number is K223015.
When was STERLINK FPS-15s Plus sterilizer with STERPACK plus cassette approved by the FDA?
STERLINK FPS-15s Plus sterilizer with STERPACK plus cassette received FDA 510(k) clearance on 2023-05-09, under approval number K223015.
What company makes STERLINK FPS-15s Plus sterilizer with STERPACK plus cassette?
STERLINK FPS-15s Plus sterilizer with STERPACK plus cassette is manufactured by Plasmapp Co,., Ltd..
What is the FDA product code for STERLINK FPS-15s Plus sterilizer with STERPACK plus cassette?
The FDA product code for STERLINK FPS-15s Plus sterilizer with STERPACK plus cassette is MLR.
Other Devices by Plasmapp Co,., Ltd.
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K212200STERLINKTM FPS-15s Plus Sterilizer with STERLOADTM Cassette
K231169STERLINK 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)
K223025Tyvek Roll with CI for STERLINK Sterilizer
K223023Terragene Bionava SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40)
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.