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FDA 510(k)

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

K-Number: K223015 · 2023-05-09

Decision Date2023-05-09
Product CodeMLR
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

STERLINK™ FPS-15s Plus sterilizer with STERPACK™ plus cassette is the device name listed in this FDA 510(k) record. The listed applicant is Plasmapp Co,., Ltd.. It received FDA 510(k) clearance on 2023-05-09 under 510(k) 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. The listed applicant is Plasmapp Co,., Ltd.. The 510(k) number is K223015.

When did STERLINK™ FPS-15s Plus sterilizer with STERPACK™ plus cassette receive FDA 510(k) clearance?

STERLINK™ FPS-15s Plus sterilizer with STERPACK™ plus cassette received FDA 510(k) clearance on 2023-05-09, under 510(k) number K223015.

Who is the listed applicant for STERLINK™ FPS-15s Plus sterilizer with STERPACK™ plus cassette?

The FDA 510(k) record lists Plasmapp Co,., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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 records listing Plasmapp Co,., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

View all 8 devices →

Related Devices (Code: MLR)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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.