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FDA 510(k)

Steriking LT-Blueline Pouches with Tyvek

K-Number: K221379 · 2023-01-04

ApplicantWipak OY
Decision Date2023-01-04
Product CodeFRG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Steriking LT-Blueline Pouches with Tyvek is the device name listed in this FDA 510(k) record. The listed applicant is Wipak OY. It received FDA 510(k) clearance on 2023-01-04 under 510(k) number K221379. 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 Steriking LT-Blueline Pouches with Tyvek?

Steriking LT-Blueline Pouches with Tyvek is a medical device that received FDA 510(k) clearance on 2023-01-04. The listed applicant is Wipak OY. The 510(k) number is K221379.

When did Steriking LT-Blueline Pouches with Tyvek receive FDA 510(k) clearance?

Steriking LT-Blueline Pouches with Tyvek received FDA 510(k) clearance on 2023-01-04, under 510(k) number K221379.

Who is the listed applicant for Steriking LT-Blueline Pouches with Tyvek?

The FDA 510(k) record lists Wipak OY as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Steriking LT-Blueline Pouches with Tyvek?

The FDA product code for Steriking LT-Blueline Pouches with Tyvek is FRG.

Other records listing Wipak OY 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.

K232625Steriking® Pouch for Robotic InstrumentsK231999Steriking® LT-Blueline Pouches with Tyvek®K231996Steriking® LT-Blueline Pouches with Tyvek®K221377SteriKing LT-Blueline Pouches with TyvekK221016Steriking Packaging for Medical DevicesK210810Steiking Packaging for Medical Devices

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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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