Class Class II

ROBOPERA (ER-R-002); ROBOPERA (ER-R-003) (K244029)

K244029 2025-09-24 Traditional
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Description

ROBOPERA (ER-R-002); ROBOPERA (ER-R-003) by Endorobotics Co., Ltd., an FDA 510(k) cleared gastroenterology, urology device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK244029
Clearance Date2025-09-24
Clearance TypeTraditional
Product CodeFDF
Regulation Number876.1500

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