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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 the device name listed in this FDA 510(k) record. The listed applicant is Plasmapp Co,., Ltd.. It received FDA 510(k) clearance on 2021-10-22 under 510(k) 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. The listed applicant is Plasmapp Co,., Ltd.. The 510(k) number is K212198.

When did Tyvek(R) Roll with CI for STERLINKTM Sterilizer receive FDA 510(k) clearance?

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

Who is the listed applicant for Tyvek(R) Roll with CI for STERLINKTM Sterilizer?

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 Tyvek(R) Roll with CI for STERLINKTM Sterilizer?

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

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.

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 SterilizerK223023Terragene Bionava SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40)K223015STERLINK™ FPS-15s Plus sterilizer with STERPACK™ plus cassetteK220345STERLINK 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)K212200STERLINKTM FPS-15s Plus Sterilizer with STERLOADTM Cassette

View all 8 devices →

Related Devices (Code: FRG)

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.

K261897HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* HEAVY-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* STANDARD-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* H300W Sterilization Wrap with ASSURE-DRY* TechnologyO&M Halyard, Inc.K252823Dukal Crepe Paper Sterilization WrapDukal, LLCK253454HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* QUICK CHECK* Sterilization Wrap; HALYARD* SEQUENTIAL Sterilization Wrap; HALYARD* SMART-FOLD* Sterilization WrapO&M Halyard, Inc.K251347Sterilization Pouch/RollSterivic Medical Co., Ltd.K251177Self-Seal Sterilization Pouch and RollGuangdong Maidi Medical Co., Ltd.K250306Chex-All Sterilization Pouches and TubesPropper Manufacturing Co., 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.

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