Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Tyvek(R) Roll with CI for STERLINKTM Sterilizer

K-Number: K212198 · 2021-10-22

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

Device Summary

Tyvek(R) Roll with CI for STERLINKTM Sterilizer is a medical device manufactured by Plasmapp Co,., Ltd.. It received FDA 510(k) clearance on 2021-10-22 under approval number K212198. The device is classified under product code FRG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Tyvek(R) Roll with CI for STERLINKTM Sterilizer?

Tyvek(R) Roll with CI for STERLINKTM Sterilizer 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 K212198.

When was Tyvek(R) Roll with CI for STERLINKTM Sterilizer approved by the FDA?

Tyvek(R) Roll with CI for STERLINKTM Sterilizer received FDA 510(k) clearance on 2021-10-22, under approval number K212198.

What company makes Tyvek(R) Roll with CI for STERLINKTM Sterilizer?

Tyvek(R) Roll with CI for STERLINKTM Sterilizer is manufactured by Plasmapp Co,., Ltd..

What is the FDA product code for Tyvek(R) Roll with CI for STERLINKTM Sterilizer?

The FDA product code for Tyvek(R) Roll with CI for STERLINKTM Sterilizer is FRG.

Other Devices by Plasmapp Co,., Ltd.

K212193Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40) 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 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: FRG)

K160595PMSSteripack Tyvek Sterilization Pouch (TP) and Roll (TY) with Chemical IndicatorPms Medikal Ambalaj Sanayi VE Ticaret Ltd Sti K162162Barrier Supreme Sterilization WrapperStandard Textile Co., Inc. K153540Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process IndicatorsSafe Secure Packaging Co., Ltd. K160755Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization WrapAhlstrom Nonwovens, LLC K160908Vis-U-All Low Temperature Sterilization Pouch/TubingSTERIS Corporation K152564Gemini Sterilization WrapMedline Industries, Inc.

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.

↑