FDA 510(k)

Steriking LT-Blueline Pouches with Tyvek

Número K: K221379 · 2023-01-04

Data da decisão2023-01-04

Código do produtoFRG

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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.

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Outros registros que listam Wipak OY como candidato(a)

K232625Steriking® Pouch for Robotic Instruments K231999Steriking® LT-Blueline Pouches with Tyvek®K231996Steriking® LT-Blueline Pouches with Tyvek®K221377SteriKing LT-Blueline Pouches with Tyvek K221016Steriking Packaging for Medical Devices K210810Steiking Packaging for Medical Devices

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Fonte oficial

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