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FDA 510(k)

STERLINKTM FPS-15s Plus Sterilizer with STERLOADTM Cassette

K-Number: K212200 · 2021-10-22

ApplicantPlasmapp Co,., Ltd.
Decision Date2021-10-22
Product CodeMLR
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

STERLINKTM FPS-15s Plus Sterilizer with STERLOADTM Cassette is a medical device manufactured by Plasmapp Co,., Ltd.. It received FDA 510(k) clearance on 2021-10-22 under approval number K212200. 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 STERLINKTM FPS-15s Plus Sterilizer with STERLOADTM Cassette?

STERLINKTM FPS-15s Plus Sterilizer with STERLOADTM Cassette is a medical device that received FDA 510(k) clearance on 2021-10-22. It is manufactured by Plasmapp Co,., Ltd.. The 510(k) number is K212200.

When was STERLINKTM FPS-15s Plus Sterilizer with STERLOADTM Cassette approved by the FDA?

STERLINKTM FPS-15s Plus Sterilizer with STERLOADTM Cassette received FDA 510(k) clearance on 2021-10-22, under approval number K212200.

What company makes STERLINKTM FPS-15s Plus Sterilizer with STERLOADTM Cassette?

STERLINKTM FPS-15s Plus Sterilizer with STERLOADTM Cassette is manufactured by Plasmapp Co,., Ltd..

What is the FDA product code for STERLINKTM FPS-15s Plus Sterilizer with STERLOADTM Cassette?

The FDA product code for STERLINKTM FPS-15s Plus Sterilizer with STERLOADTM Cassette is MLR.

Other Devices by Plasmapp Co,., Ltd.

K212198Tyvek(R) Roll with CI for STERLINKTM Sterilizer K212193Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40) 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 K223015STERLINK™ FPS-15s Plus sterilizer with STERPACK™ plus cassette K223023Terragene Bionava SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40)

View all 8 devices →

Related Devices (Code: MLR)

K160818STERRAD® NX Sterilizer with ALLClear™ TechnologyAdvanced Sterilization Products K160903STERRAD 100NX Sterilizer with ALLClearTM TechnologyAdvanced Sterilization Products K160433V-PRO® 1 Plus and V-PRO® maX Low TemperatureSTERIS Corporation K151725STERRAD NX Sterilizer, STERRAD 100NX SterilizerAdvanced Sterilization Products K162413AMSCO V-PRO 1 Low Temperature Sterilization System, AMSCO V-PRO 1 Plus Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization SystemSTERIS Corporation K162007STERRAD NX SterilizerAdvanced Sterilization Products

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.

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