FDA 510(k)

CROMA Electrosurgical Generator (PRD-EMR-050)

Número K: K242983 · 2025-02-05

Data da decisão2025-02-05

Código do produtoGEI

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

CROMA Electrosurgical Generator (PRD-EMR-050) is the device name listed in this FDA 510(k) record. The listed applicant is Creo Medical, Ltd.. It received FDA 510(k) clearance on 2025-02-05 under 510(k) number K242983. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the CROMA Electrosurgical Generator (PRD-EMR-050)?

CROMA Electrosurgical Generator (PRD-EMR-050) is a medical device that received FDA 510(k) clearance on 2025-02-05. The listed applicant is Creo Medical, Ltd.. The 510(k) number is K242983.

When did CROMA Electrosurgical Generator (PRD-EMR-050) receive FDA 510(k) clearance?

CROMA Electrosurgical Generator (PRD-EMR-050) received FDA 510(k) clearance on 2025-02-05, under 510(k) number K242983.

Who is the listed applicant for CROMA Electrosurgical Generator (PRD-EMR-050)?

The FDA 510(k) record lists Creo Medical, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CROMA Electrosurgical Generator (PRD-EMR-050)?

The FDA product code for CROMA Electrosurgical Generator (PRD-EMR-050) is GEI.

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Fonte oficial

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