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FDA 510(k)

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

K-Number: K244029 · 2025-09-24

ApplicantEndorobotics Co., Ltd.
Decision Date2025-09-24
Product CodeFDF
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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