FDA 510(k)

Celerity 5 HP Biological Indicator (LCB052)

Número K: K260766 · 2026-04-08

Data da decisão2026-04-08

Código do produtoFRC

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Celerity 5 HP Biological Indicator (LCB052) is the device name listed in this FDA 510(k) record. The listed applicant is STERIS Corporation. It received FDA 510(k) clearance on 2026-04-08 under 510(k) number K260766. The device is classified under product code FRC. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Celerity 5 HP Biological Indicator (LCB052)?

Celerity 5 HP Biological Indicator (LCB052) is a medical device that received FDA 510(k) clearance on 2026-04-08. The listed applicant is STERIS Corporation. The 510(k) number is K260766.

When did Celerity 5 HP Biological Indicator (LCB052) receive FDA 510(k) clearance?

Celerity 5 HP Biological Indicator (LCB052) received FDA 510(k) clearance on 2026-04-08, under 510(k) number K260766.

Who is the listed applicant for Celerity 5 HP Biological Indicator (LCB052)?

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

What is the FDA product code for Celerity 5 HP Biological Indicator (LCB052)?

The FDA product code for Celerity 5 HP Biological Indicator (LCB052) is FRC.

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Fonte oficial

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