FDA 510(k)

ROBOPERA (ER-R-002); ROBOPERA (ER-R-003)

Número K: K244029 · 2025-09-24

Data da decisão2025-09-24

Código do produtoFDF

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

ROBOPERA (ER-R-002); ROBOPERA (ER-R-003) is the device name listed in this FDA 510(k) record. The listed applicant is Endorobotics Co., Ltd.. It received FDA 510(k) clearance on 2025-09-24 under 510(k) number K244029. The device is classified under product code FDF. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the ROBOPERA (ER-R-002); ROBOPERA (ER-R-003)?

ROBOPERA (ER-R-002); ROBOPERA (ER-R-003) is a medical device that received FDA 510(k) clearance on 2025-09-24. The listed applicant is Endorobotics Co., Ltd.. The 510(k) number is K244029.

When did ROBOPERA (ER-R-002); ROBOPERA (ER-R-003) receive FDA 510(k) clearance?

ROBOPERA (ER-R-002); ROBOPERA (ER-R-003) received FDA 510(k) clearance on 2025-09-24, under 510(k) number K244029.

Who is the listed applicant for ROBOPERA (ER-R-002); ROBOPERA (ER-R-003)?

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

What is the FDA product code for ROBOPERA (ER-R-002); ROBOPERA (ER-R-003)?

The FDA product code for ROBOPERA (ER-R-002); ROBOPERA (ER-R-003) is FDF.

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