FDA 510(k)

STEP-1 PumEtch

Número K: K213093 · 2022-01-28

Data da decisão2022-01-28

Código do produtoKLE

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

STEP-1 PumEtch is the device name listed in this FDA 510(k) record. The listed applicant is Rounding Third, LLC. It received FDA 510(k) clearance on 2022-01-28 under 510(k) number K213093. The device is classified under product code KLE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the STEP-1 PumEtch?

STEP-1 PumEtch is a medical device that received FDA 510(k) clearance on 2022-01-28. The listed applicant is Rounding Third, LLC. The 510(k) number is K213093.

When did STEP-1 PumEtch receive FDA 510(k) clearance?

STEP-1 PumEtch received FDA 510(k) clearance on 2022-01-28, under 510(k) number K213093.

Who is the listed applicant for STEP-1 PumEtch?

The FDA 510(k) record lists Rounding Third, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STEP-1 PumEtch?

The FDA product code for STEP-1 PumEtch is KLE.

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